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10 January 2013	Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling	Here	Here	Guidance	Guidance	Pharmaceutical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

Return to listing