FDA Federal Register Tracker
| Date | Title | In Focus | Federal Register | FDA | Document Type | Product Type |
| 3 January 2013 | Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications | Here | Here | Guidance | Guidance | Biologic, Pharmaceutical |
| 4 January 2013 | Advisory Committee for Reproductive Health Drugs | Here | Meeting | Meeting | Pharmaceutical | |
| 4 January 2013 | Medical Imaging Drugs Advisory Committee | Here | Meeting | Meeting | Medical Device | |
| 4 January 2013 | Availability of Safety and Effectiveness Summaries for Premarket Approval Applications | Here | PMA Update | Medical Device | ||
| 4 January 2013 | Accessible Medical Device Labeling in a Standard Content and Format | Here | Here | Meeting | Meeting | Medical Device |
| 4 January 2013 | Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Withdrawal | Here | Here | OMB Collection | Medical Device | |
| 7 January 2013 | Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Pulmonary/Cardiac Support | Here | Here | Reclassification | Medical Device | |
| 7 January 2013 | Cardiovascular Devices; Reclassification of External Cardiac Compressor | Here | Here | Reclassification | Medical Device | |
| 9 January 2013 | Privacy Act, Exempt Record System; Withdrawal | Here | Here | Regulation | General | |
| 9 January 2013 | Privacy Act, Exempt Record System; Withdrawal | Here | Here | Regulation | General | |
| 10 January 2013 | Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant | Here | Here | Reclassification | Medical Device | |
| 10 January 2013 | Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling | Here | Here | Guidance | Guidance | Pharmaceutical |
| 10 January 2013 | Blood Products Advisory Committee | Here | Here | Meeting | Meeting | Blood Product |
| 10 January 2013 | Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee | Here | Meeting | Meeting | Pharmaceutical | |
| 13 January 2013 | Modifications to the List of Recognized Standards, Recognition List Number: 030 | Here | Here | Standards | Medical Device | |
| 13 January 2013 | Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need | Here | Here | Meeting | Meeting | Pharmaceutical |
| 16 January 2013 | Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal | Here | OMB Collection | General | ||
| 17 January 2013 | Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee Rates for Fiscal Year 2013 | Here | Here | Administrative | Pharmaceutical | |
| 18 January 2013 | Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices | Here | Here | Reclassification | Medical Device | |
| 18 January 2013 | Notification Procedures for Statements on Dietary Supplements | Here | OMB Collection | Dietary Supplement | ||
| 22 January 2013 | Current Good Manufacturing Practice Requirements for Combination Products | Here | Here | Regulation | Combination Product | |
| 22 January 2013 | Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | Here | Administrative | Dietary Supplement | ||
| 22 January 2013 | Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval Modifications to a Combination Product Approved Under Certain Marketing Applications | Here | Here | Guidance | Guidance | Combination Product |
| 22 January 2013 | Electronic Submission Process for Requesting Export Certificates From the Center for Devices and Radiological Health | Here | Here | Administrative | Medical Device | |
| 24 January 2013 | Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations | Here | Here | Guidance | Guidance | Medical Device |
| 24 January 2013 | Clinical Flow Cytometry in Hematologic Malignancies | Here | Meeting | Meeting | Medical Device | |
| 25 January 2013 | Ophthalmic Devices; Classification of the Scleral Plug | Here | Reclassification | Medical Device | ||
| 25 January 2013 | Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008 | Here | Here | OMB Collection | Pharmaceutical | |
| 25 January 2013 | Vaccines and Related Biological Products Advisory Committee | Here | Meeting | Meeting | Biologic | |
| 28 January 2013 | New Animal Drugs; Cefpodoxime; Meloxicam | Here | Administrative | Veterinary | ||
| 28 January 2013 | 2013 Assuring Radiation Protection | Here | Here | Administrative | Medical Device | |
| 28 January 2013 | Electronic Study Data Submission; Data Standard Support End Date | Here | Here | Administrative | Pharmaceutical | |
| 28 January 2013 | Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling | Here | Here | Guidance | Guidance | Pharmaceutical |
| 28 January 2013 | Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What Should We Do About It? | Here | Here | Meeting | Meeting | Pharmaceutical |
| 29 January 2013 | Statement of Organization, Functions, and Delegations of Authority | Here | Administrative | Veterinary | ||
| 30 January 2013 | Science Board to the Food and Drug Administration | Here | Here | Meeting | Meeting | General |
| 31 January 2013 | Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification | Here | OMB Submission | Medical Device | ||
| 31 January 2013 | Medical Devices; Inspection by Accredited Persons Program | Here | OMB Submission | Medical Device | ||
| 31 January 2013 | Determination That DIFFERIN (Adapalene) Solution, 0.1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Here | Administrative | Pharmaceutical | ||
| 31 January 2013 | Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis | Here | Here | Meeting | Meeting | General |
| 31 January 2013 | Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments; Correction | Here | Administrative | General | ||
| 31 January 2013 | Determination of Regulatory Review Period for Purposes of Patent Extension; BEYAZ | Here | Administrative | Pharmaceutical | ||
| 31 January 2013 | Determination of Regulatory Review Period for Purposes of Patent Extension; XALKORI | Here | Administrative | Pharmaceutical | ||
| 4 February 2013 | International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of Pharmaceuticals | Here | Here | Guidance | Guidance | Pharmaceutical |
| 4 February 2013 | Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment Period | Here | Guidance | Guidance | Pharmaceutical, Biologic | |
| 6 February 2013 | Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement Initiative | Here | Here | Administrative | Pharmaceutical | |
| 6 February 2013 | Training Program for Regulatory Project Managers | Here | Here | Administrative | Pharmaceutical | |
| 6 February 2013 | Medical Device User Fee Cover Sheet, Form FDA 3601 | Here | Administrative | Medical Device | ||
| 6 February 2013 | Administrative Detention and Banned Medical Devices | Here | Administrative | Medical Device | ||
| 7 February 2013 | Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis | Here | Reclassification | Medical Device | ||
| 7 February 2013 | Request for Nominations for Voting Members on Public Advisory Panels or Committees | Here | Here | Meeting | Meeting | Medical Device |
| 8 February 2013 | Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight | Here | Reclassification | Medical Device | ||
| 8 February 2013 | Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable | Here | OMB Submission | General | ||
| 8 February 2013 | Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease | Here | Here | Guidance | Guidance | Pharmaceutical |
| 8 February 2013 | International Drug Scheduling; Convention on Psychotropic Substances; World Health Organization Scheduling Recommendations for Gamma-hydroxybutyric Acid | Here | Here | Administrative | Pharmaceutical | |
| 11 February 2013 | Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products | Here | Here | Guidance | Guidance | Pharmaceutical, Biologic |
| 11 February 2013 | Food and Drug Administration/Xavier University PharmaLink Conference-Quality in a Global Supply Chain | Here | Meeting | Meeting | Pharmaceutical | |
| 12 February 2013 | Food and Drug Administration Drug Shortages Task Force and Strategic Plan | Here | Here | Administrative | Pharmaceutical | |
| 13 February 2013 | Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes | Here | OMB Submission | Medical Device | ||
| 13 February 2013 | Documents To Support Submission of an Electronic Common Technical Document | Here | Here | Administrative | Pharmaceutical | |
| 13 February 2013 | Annual Computational Science Symposium; Conference | Here | Meeting | Meeting | Pharmaceutical | |
| 13 February 2013 | Global Quality Systems-An Integrated Approach To Improving Medical Product Safety | Here | Meeting | Meeting | Pharmaceutical, Medical Device | |
| 15 February 2013 | Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers: Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I | Here | Here | Guidance | Guidance | Medical Device |
| 15 February 2013 | Guidance for Industry and Food and Drug Administration Staff: Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation | Here | Here | Guidance | Guidance | Medical Device |
| 15 February 2013 | Circulatory System Devices Panel of the Medical Devices Advisory Committee | Here | Meeting | Meeting | Medical Device | |
| 15 February 2013 | Transmissible Spongiform Encephalopathies Advisory Committee | Here | Meeting | Meeting | Blood Product | |
| 19 February 2013 | Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure | Here | Here | Regulation | Medical Device | |
| 19 February 2013 | Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act | Here | Here | OMB Submission | Pharmaceutical, Biologic | |
| 19 February 2013 | Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act | Here | Here | Guidance | Guidance | Medical Device |
| 19 February 2013 | Neonatal Subcommittee of the Pediatric Advisory Committee | Here | Meeting | Meeting | General | |
| 20 February 2013 | Environmental Impact Considerations | Here | OMB Submission | General | ||
| 21 February 2013 | Extreme Weather Effects on Medical Device Safety and Quality | Here | Here | Administrative | Medical Device | |
| 21 February 2013 | Device Good Manufacturing Practice Advisory Committee | Here | Here | Meeting | Meeting | Medical Device |
| 22 February 2013 | Draft Guidance for Industry and Food and Drug Administration Staff: Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements | Here | Here | Guidance | Guidance | Medical Device |
| 22 February 2013 | Determination of Regulatory Review Period for Purposes of Patent Extension; Sapien Transcatheter Heart Valve | Here | Administrative | Medical Device | ||
| 22 February 2013 | Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels | Here | Here | Administrative | General | |
| 25 February 2013 | Fecal Microbiota for Transplantation | Here | Here | Meeting | Meeting | Biologic |
| 25 February 2013 | Pediatric Advisory Committee | Here | Meeting | Meeting | Biologic, Pharmaceutical | |
| 25 February 2013 | Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee | Here | Meeting | Meeting | Biologic | |
| 25 February 2013 | Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidance | Here | Guidance | Guidance | Dietary Supplement | |
| 25 February 2013 | Guidance for Industry on Labeling for Human Prescription Drug and Biological Products-Implementing the Physician Labeling Rule Content and Format Requirements | Here | Here | Guidance | Guidance | Biologic, Pharmaceutical |
| 25 February 2013 | Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting Hepatitis C Virus Resistance Data | Here | Here | Guidance | Guidance | Pharmaceutical |
| 25 February 2013 | Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices | Here | Here | Regulation | Medical Device | |
| 26 February 2013 | Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products | Here | Regulation | General | ||
| 26 February 2013 | Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application | Here | OMB Submission | Pharmaceutical | ||
| 26 February 2013 | Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis | Here | Here | Guidance | Guidance | Blood Product |
| 26 February 2013 | Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators | Here | Here | Guidance | Guidance | General |
| 26 February 2013 | Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma | Here | Here | Guidance | Guidance | Blood Product |
| 26 February 2013 | Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013 | Here | Meeting | Meeting | General | |
| 27 February 2013 | Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee | Here | Meeting | Meeting | Medical Device | |
| 27 February 2013 | Oncologic Drugs Advisory Committee | Here | Meeting | Meeting | Pharmaceutical | |
| 27 February 2013 | Ophthalmic Devices Panel of the Medical Devices Advisory Committee | Here | Meeting | Meeting | Medical Device | |
| 27 February 2013 | Psychopharmacologic Drugs Advisory Committee | Here | Meeting | Meeting | Pharmaceutical | |
| 27 February 2013 | Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice | Here | Meeting | Meeting | General | |
| 28 February 2013 | Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling | Here | Here | Guidance | Guidance | Biologic, Pharmaceutical |
| 28 February 2013 | Mammography Quality Standards Act Requirements | Here | OMB Submission | Medical Device | ||
| 28 February 2013 | Determination of Regulatory Review Period for Purposes of Patent Extension; LAVIV | Here | Administrative | Biologic | ||
| 28 February 2013 | Determination of Regulatory Review Period for Purposes of Patent Extension; ZYTIGA | Here | Administrative | Pharmaceutical | ||
| 4 March 2013 | Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration Staff | Here | Here | Guidance | Guidance | Medical Device |
| 4 March 2013 | Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport | Here | Regulation | Medical Device | ||
| 4 March 2013 | Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator | Here | Regulation | Medical Device | ||
| 4 March 2013 | Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Here | Administrative | Pharmaceutical | ||
| 5 March 2913 | Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions | Here | Here | Guidance | Guidance | Medical Device |
| 5 March 2913 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on "Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing" (VICH GL23(R)) | Here | Guidance | Guidance | Veterinary | |
| 5 March 2913 | International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on "Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish a Microbiological Acceptable Daily Intake (ADI)" (VICH GL36(R)) | Here | Guidance | Guidance | Veterinary | |
| 6 March 2013 | Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; | Here | Administrative | Dietary Supplement | ||
| 6 March 2013 | Cheng Yi Liang: Debarment Order | Here | Here | Administrative | General | |
| 6 March 2013 | Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses | Here | Here | Guidance | Guidance | Medical Device |
| 7 March 2013 | New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N | Here | Administrative | Veterinary | ||
| 7 March 2013 | Veterinary Oversight of Antimicrobial Use in Livestock: Impact on Stakeholders | Here | Meeting | Meeting | Veterinary | |
| 7 March 2013 | Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications | Here | Administrative | Veterinary | ||
| 8 March 2013 | Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide | Here | Guidance | Guidance | Dietary Supplement | |
| 8 March 2013 | Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan | Here | Administrative | Biologic, Pharmaceutical | ||
| 11 March 2013 | Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex | Here | Here | Guidance | Guidance | Medical Device |
| 11 March 2013 | Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis | Here | Here | Meeting | Meeting | Biologic, Pharmaceutical |
| 12 March 2013 | Cellular, Tissue and Gene Therapies Advisory Committee | Here | Meeting | Meeting | Biologic | |
| 13 March 2013 | Guidance on Reagents for Detection of Specific Novel Influenza A Viruses | Here | OMB Submission | Biologic | ||
| 13 March 2013 | Cooperative Agreement To Support Regulatory Research Related to Food and Drug Administration Commitments Under the 2012 Prescription Drug User Fee Act | Here | Here | Administrative | Biologic, Pharmaceutical | |
| 13 March 2013 | Draft Guidance for Industry and Review Staff on Formal Dispute Resolution: Appeals Above the Division Level | Here | Here | Guidance | Guidance | Biologic, Pharmaceutical |
| 13 March 2013 | Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation | Here | Here | Guidance | Guidance | Pharmaceutical |
| 13 March 2013 | Food and Drug Administration/Xavier University Global Medical Device Conference | Here | Meeting | Meeting | Medical Device | |
| 14 March 2013 | Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee | Here | Meeting | Meeting | Biologic | |
| 15 March 2013 | Institutional Review Boards; Correcting Amendments | Here | Regulation | |||
| 15 March 2013 | Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations | Here | Here | Meeting | Meeting | Biologic, Medical Device |
| 18 March 2013 | Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump-Premarket Notification [510(k)] Submissions | Here | OMB Submission | Medical Device | ||
| 18 March 2013 | Center for Drug Evaluation and Research Medical Policy Council | Here | Here | Administrative | Biologic, Medical Device | |
| 18 March 2013 | International Conference on Harmonisation; Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals | Here | Administrative | Pharmaceutical | ||
| 18 March 2013 | General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee | Here | Meeting | Meeting | Medical Device | |
| 18 March 2013 | Impax Laboratories, Inc.; Withdrawal of Approval of Bupropion Hydrochloride Extended-Release Tablets, 300 Milligrams | Here | Here | Administrative | Pharmaceutical | |
| 20 March 2013 | Public Hearing Before a Public Advisory Committee; Technical Amendments | Here | Regulation | General | ||
| 20 March 2013 | Current Good Manufacturing Practice for Positron Emission Tomography Drugs | Here | OMB Submission | Pharmaceutical | ||
| 21 March 2013 | Pulmonary-Allergy Drugs Advisory Committee | Here | Meeting | Meeting | Pharmaceutical | |
| 21 March 2013 | Risk Communications Advisory Committee | Here | Here | Meeting | Meeting | General |
| 21 March 2013 | Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications | Here | PMA Update | Medical Device | ||
| 22 March 2013 | New Animal Drugs; Changes of Sponsor | Here | Administrative | Veterinary | ||
| 22 March 2013 | Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases | Here | Here | Administrative | Pharmaceutical | |
| 25 March 2013 | New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide | Here | Administrative | Veterinary | ||
| 25 March 2013 | Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System | Here | Here | Regulation | Medical Device | |
| 25 March 2013 | Determination That BENADRYL (diphenhydramine hydrochloride) Injection and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Here | Administrative | Pharmaceutical | ||
| 25 March 2013 | Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Extension of Comment Period | Here | Meeting | Meeting | Medical Device | |
| 26 March 2013 | Service of Process on Manufacturers; Manufacturers Importing Electronic Products Into the United States; Agent Designation; Change of Address | Here | Administrative | Medical Device | ||
| 26 March 2013 | Medical Devices; Technical Amendment | Here | Administrative | Medical Device | ||
| 26 March 2013 | Food Labeling; Notification Procedures for Statements on Dietary Supplements | Here | Administrative | Dietary Supplement | ||
| 26 March 2013 | Determination That QUESTRAN (Cholestyramine for Oral Suspension, USP), Equivalent to 4 Grams, and QUESTRAN LIGHT (Cholestyramine for Oral Suspension, USP), Equivalent to 4 Grams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Here | Administrative | Pharmaceutical | ||
| 26 March 2013 | Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; Availability | Here | Here | Guidance | Guidance | Blood Product |
| 27 March 2013 | Summit on Color in Medical Imaging; Cosponsored Public Workshop; Request for Comments | Here | Here | Meeting | Meeting | Medical Device |
| 27 March 2013 | Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | Here | OMB Submission | Dietary Supplement | ||
| 28 March 2013 | Guidance for Industry and Food and Drug Administration Staff: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi | Here | Here | Guidance | Guidance | Medical Device |
| 29 March 2013 | Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel | Here | Standards | Pharmaceutical | ||
| 1 April 2013 | Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers | Here | Regulation | Medical Device | ||
| 1 April 2013 | Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants | Here | Here | Guidance | Guidance | Biologic |
| 1 April 2013 | Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment Addendum | Here | Guidance | Guidance | Pharmaceutical | |
| 2 April 2013 | Change of Address; Biologics License Applications; Technical Amendment | Here | Administrative | Biologic | ||
| 2 April 2013 | Center for Devices and Radiological Health: Experiential Learning Program | Here | Here | Administrative | Medical Device | |
| 2 April 2013 | Guidance for Industry and Food and Drug Administration Staff: User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications | Here | Here | Guidance | Guidance | Biologic, Medical Device |
| 2 April 2013 | Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Extension of Comment Period | Here | Administrative | Dietary Supplement | ||
| 2 April 2013 | International Consortium of Cardiovascular Registries | Here | Here | Meeting | Meeting | Medical Device |
| 2 April 2013 | Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule | Here | Meeting | Meeting | Medical Device | |
| 2 April 2013 | Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use | Here | Here | Administrative | Pharmaceutical, Medical Device | |
| 2 April 2013 | New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin | Here | Administrative | Veterinary | ||
| 3 April 2013 | Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements | Here | OMB Submission | Medical Device | ||
| 3 April 2013 | Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization Standard 11040-4 | Here | Here | Guidance | Guidance | Medical Device |
| 3 April 2013 | Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose | Here | Reclassification | Medical Device | ||
| 4 April 2013 | 2013 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference: Driving Quality and Compliance Throughout the Product Life Cycle in a Global Regulatory Environment | Here | Meeting | Meeting | Pharmaceutical | |
| 4 April 2013 | Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food | Here | Administrative | Dietary Supplement | ||
| 4 April 2013 | Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice | Here | Meeting | Administrative | Pharmaceutical | |
| 4 April 2013 | Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting | Here | Meeting | Meeting | Medical Device | |
| 4 April 2013 | Peripheral and Central Nervous System Drugs Advisory Committee | Here | Meeting | Meeting | Pharmaceutical | |
| 5 April 2013 | Agreement for Shipment of Devices for Sterilization | Here | OMB Submission | Medical Device | ||
| 5 April 2013 | Export of Medical Devices; Foreign Letters of Approval | Here | OMB Submission | Medical Device | ||
| 5 April 2013 | 2013 Medical Countermeasures Initiative Regulatory Science Symposium | Here | Meeting | Meeting | Medical Device | |
| 5 April 2013 | Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice | Here | Meeting | Meeting | General | |
| 5 April 2013 | Vaccines and Related Biological Products Advisory Committee | Here | Meeting | Meeting | Biologic | |
| 5 April 2013 | Pediatric Device Consortia Grant Program | Here | Administrative | Medical Device | ||
| 5 April 2013 | Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices | Here | Meeting | Meeting | Medical Device | |
| 8 April 2013 | Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Investigational New Drug Applications | Here | Here | Administrative | Biologic | |
| 8 April 2013 | Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations | Here | Standards | Pharmaceutical | ||
| 8 April 2013 | Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) | Here | Here | Guidance | Guidance | Biologic, Pharmaceutical |
| 8 April 2013 | Center for Devices and Radiological Health: Health of Women Program | Here | Here | Meeting | Meeting | Medical Device |
| 9 April 2013 | New Animal Drugs; Change of Sponsor | Here | Administrative | Veterinary | ||
| 9 April 2013 | Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation Act | Here | Here | Administrative | Biologic, Pharmaceutical | |
| 9 April 2013 | Draft Guidance for Industry and Food and Drug Administration Staff: Molecular Diagnostic Instruments With Combined Functions | Here | Here | Guidance | Guidance | Medical Device |
| 11 April 2013 | Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products | Here | Here | Guidance | Guidance | Pharmaceutical |
| 11 April 2013 | Guidance for Industry and Food and Drug Administration Staff: Medical Device Classification Product Codes | Here | Here | Guidance | Guidance | Medical Device |
| 11 April 2013 | Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013-2015 | Here | Here | Administrative | Biologic, Pharmaceutical | |
| 15 April 2013 | International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk | Here | Here | Guidance | Guidance | Pharmaceutical |
| 15 April 2013 | Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee | Here | Meeting | Meeting | Pharmaceutical | |
| 16 April 2013 | Generic Drug Facilities, Sites, and Organizations | Here | Here | Administrative | Pharmaceutical | |
| 16 April 2013 | Document to Support Submission of an Electronic Common Technical Document-Specifications for File Format Types Using Electronic Common Technical Document Specifications | Here | Here | Administrative | Biologic, Pharmaceutical | |
| 17 April 2013 | Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework for Preventing Cross-Contamination | Here | Here | Guidance | Guidance | Pharmaceutical |
| 18 April 2013 | Determination That the OXYCONTIN (Oxycodone Hydrochloride) Drug Products Covered by New Drug Application 20-553 Were Withdrawn From Sale for Reasons of Safety or Effectiveness | Here | Here | Administrative | Pharmaceutical | |
| 18 April 2013 | Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims | Here | OMB Submission | Biologic, Pharmaceutical | ||
| 19 April 2013 | Use of Certain Symbols in Labeling | Here | Here | Regulation | Medical Device | |
| 19 April 2013 | Clinical Laboratory Improvement Amendments Waiver Applications | Here | OMB Submission | General | ||
| 19 April 2013 | Electronic Submission of Medical Device Registration and Listing | Here | OMB Submission | Medical Device | ||
| 19 April 2013 | Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification | Here | OMB Submission | Medical Device | ||
| 19 April 2013 | Health Care Professional Survey of Prescription Drug Promotion | Here | Here | OMB Submission | Biologic, Pharmaceutical | |
| 23 April 2013 | Investigational Device Exemptions Reports and Records | Here | OMB Submission | Medical Device | ||
| 23 April 2013 | Annual Public Meeting of Reagan-Udall Foundation | Here | Here | Meeting | Meeting | General |
| 23 April 2013 | Draft Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" | Here | Here | Guidance | Guidance | Biologic |
| 23 April 2013 | Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the Duration of the Program | Here | Here | Administrative | Medical Device | |
| 24 April 2013 | Protection of Human Subjects: Informed Consent; Institutional Review Boards | Here | OMB Submission | General | ||
| 23 April 2013 | Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising | Here | Here | OMB Submission | Pharmaceutical | |
| 24 April 2013 | Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors | Here | Here | Guidance | Guidance | Biologic, Pharmaceutical |
| 25 April 2013 | Guidance for Industry and Food and Drug Administration Staff: Assay Migration Studies for In Vitro Diagnostic Devices | Here | Here | Guidance | Guidance | Medical Device |
| 25 April 2013 | Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee | Here | Meeting | Meeting | Medical Device | |
| 26 April 2013 | Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals | Here | Here | Guidance | Guidance | Pharmaceutical |
| 30 April 2013 | New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin | Here | Administrative | Veterinary | ||
| 30 April 2013 | Abbreviated New Animal Drug Applications | Here | OMB Submission | Veterinary | ||
| 1 May 2013 | Guidance: Emergency Use Authorization of Medical Products | Here | OMB Submission | General | ||
| 1 May 2013 | Medical Devices; Inspection by Accredited Persons Program | Here | OMB Submission | Medical Device | ||
| 1 May 2013 | Ashley Brandon Foyle: Debarment Order | Here | Administrative | Pharmaceutical | ||
| 2 May 2013 | Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications | Here | OMB Submission | Medical Device | ||
| 2 May 2013 | Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee | Here | Meeting | Meeting | Medical Device | |
| 2 May 2013 | Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program | Here | Here | Administrative | Biologic, Pharmaceutical | |
| 6 May 2013 | Electronic Submission Process for Voluntary Complaints to the Center for Devices and Radiological Health | Here | Here | OMB Submission | Medical Device | |
| 6 May 2013 | An Evaluation of the Prescription Drug User Fee Act Workload Adjuster | Here | Administrative | Biologic, Pharmaceutical | ||
| 6 May 2013 | Food and Drug Administration/International Society for Pharmaceutical Engineering Co-Sponsorship Educational Workshop: Redefining the `C' in CGMP (Current Good Manufacturing Practices): Creating, Implementing, and Sustaining a Culture of Quality | Here | Meeting | Meeting | Biologic, Pharmaceutical | |
| 8 May 2013 | Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act | Here | OMB Submission | Biologic, Pharmaceutical | ||
| 8 May 2013 | Public Health Service Guideline on Infectious Disease Issues on Xenotransplantation | Here | OMB Submission | Biologic | ||
| 8 May 2013 | David Freeman: Debarment Order | Here | Administrative | Pharmaceutical | ||
| 8 May 2013 | Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components | Here | Here | Guidance | Guidance | Blood Product |
| 8 May 2013 | 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Public Meeting | Here | Here | Meeting | Meeting | Medical Device |
| 8 May 2013 | Microbiology Devices Panel of the Medical Devices Advisory Committee | Here | Meeting | Meeting | Medical Device | |
| 9 May 2013 | General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products | Here | Here | Regulation | Medical Device | |
| 9 May 2013 | Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and Answers | Here | Here | Guidance | Guidance | Biologic, Pharmaceutical |
| 9 May 2013 | Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use-Questions and Answers | Here | Here | Guidance | Guidance | Biologic, Pharmaceutical |
| 9 May 2013 | Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing | Here | Here | Meeting | Meeting | Pharmaceutical |
| 10 May 2013 | Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs | Here | OMB Submission | Biologic, Pharmaceutical | ||
| 10 May 2013 | Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable | Here | OMB Submission | Medical Device | ||
| 10 May 2013 | Anesthetic and Analgesic Drug Products Advisory Committee | Here | Meeting | Biologic, Pharmaceutical | ||
| 13 May 2013 | New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor | Here | Administrative | Veterinary | ||
| 13 May 2013 | New Animal Drug Applications and Supporting Regulations and Form FDA 356V | Here | OMB Submission | Veterinary | ||
| 13 May 2013 | Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Here | Administrative | Pharmaceutical | ||
| 13 May 2013 | Dental Products Panel of the Medical Devices Advisory Committee | Here | Meeting | Meeting | Medical Device | |
| 14 May 2013 | Communicating Composite Scores in Direct-to-Consumer Advertising | Here | Here | OMB Submission | General | |
| 14 May 2013 | Prescription Drug Product Labeling; Medication Guide Requirements | Here | OMB Submission | Biologic, Pharmaceutical | ||
| 14 May 2013 | Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data | Here | Here | Guidance | Guidance | Biologic, Pharmaceutical |
| 16 May 2013 | Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker | Here | Here | |||
| 16 May 2013 | Guidance for Industry on How To Submit Information in Electronic Format to Center for Veterinary Medicine Using the Food and Drug Administration's Electronic Submission Gateway | Here | OMB Submission | Veterinary | ||
| 16 May 2013 | Bar Code Label Requirement for Human Drug and Biological Products | Here | OMB Submission | Biologic, Pharmaceutical | ||
| 16 May 2013 | Postmarket Surveillance | Here | OMB Submission | Medical Device | ||
| 17 May 2013 | Guidance for Industry and FDA Staff: Center for Devices and Radiological Health Appeals Processes | Here | Here | Guidance | Guidance | Medical Device |
| 17 May 2013 | Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A; Draft Guidance for Industry and Food and Drug Administration Staff | Here | Here | Guidance | Guidance | Medical Device |
| 17 May 2013 | Anesthetic and Analgesic Drug Products Advisory Committee | Here | Meeting | Meeting | Pharmaceutical |