Regulatory Focus™ > News Articles > FDA Federal Register Tracker

FDA Federal Register Tracker

Posted 19 May 2013 | By

DateTitleIn FocusFederal RegisterFDADocument TypeProduct Type
3 January 2013Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD SpecificationsHereHereGuidanceGuidanceBiologic, Pharmaceutical
4 January 2013Advisory Committee for Reproductive Health DrugsHereMeetingMeetingPharmaceutical
4 January 2013Medical Imaging Drugs Advisory CommitteeHereMeetingMeetingMedical Device
4 January 2013Availability of Safety and Effectiveness Summaries for Premarket Approval ApplicationsHerePMA UpdateMedical Device
4 January 2013Accessible Medical Device Labeling in a Standard Content and FormatHereHereMeetingMeetingMedical Device
4 January 2013Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; WithdrawalHereHereOMB CollectionMedical Device
7 January 2013Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Pulmonary/Cardiac SupportHereHereReclassificationMedical Device
7 January 2013Cardiovascular Devices; Reclassification of External Cardiac CompressorHereHereReclassificationMedical Device
9 January 2013Privacy Act, Exempt Record System; WithdrawalHereHereRegulationGeneral
9 January 2013Privacy Act, Exempt Record System; WithdrawalHereHereRegulationGeneral
10 January 2013Dental Devices; Reclassification of Blade-Form Endosseous Dental ImplantHereHereReclassificationMedical Device
10 January 2013Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and LabelingHereHereGuidanceGuidancePharmaceutical
10 January 2013Blood Products Advisory CommitteeHereHereMeetingMeetingBlood Product
10 January 2013Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory CommitteeHereMeetingMeetingPharmaceutical
13 January 2013Modifications to the List of Recognized Standards, Recognition List Number: 030HereHereStandardsMedical Device
13 January 2013Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical NeedHereHereMeetingMeetingPharmaceutical
16 January 2013Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting PortalHereOMB CollectionGeneral
17 January 2013Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee Rates for Fiscal Year 2013HereHereAdministrativePharmaceutical
18 January 2013Effective Date of Requirement for Premarket Approval for Two Class III Preamendments DevicesHereHereReclassificationMedical Device
18 January 2013Notification Procedures for Statements on Dietary SupplementsHereOMB CollectionDietary Supplement
22 January 2013Current Good Manufacturing Practice Requirements for Combination ProductsHereHereRegulationCombination Product
22 January 2013Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002HereAdministrativeDietary Supplement
22 January 2013Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval Modifications to a Combination Product Approved Under Certain Marketing ApplicationsHereHereGuidanceGuidanceCombination Product
22 January 2013Electronic Submission Process for Requesting Export Certificates From the Center for Devices and Radiological HealthHereHereAdministrativeMedical Device
24 January 2013Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) DesignationsHereHereGuidanceGuidanceMedical Device
24 January 2013Clinical Flow Cytometry in Hematologic MalignanciesHereMeetingMeetingMedical Device
25 January 2013Ophthalmic Devices; Classification of the Scleral PlugHereReclassificationMedical Device
25 January 2013Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008HereHereOMB CollectionPharmaceutical
25 January 2013Vaccines and Related Biological Products Advisory CommitteeHereMeetingMeetingBiologic
28 January 2013New Animal Drugs; Cefpodoxime; MeloxicamHereAdministrativeVeterinary
28 January 20132013 Assuring Radiation ProtectionHereHereAdministrativeMedical Device
28 January 2013Electronic Study Data Submission; Data Standard Support End DateHereHereAdministrativePharmaceutical
28 January 2013Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for LabelingHereHereGuidanceGuidancePharmaceutical
28 January 2013Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What Should We Do About It?HereHereMeetingMeetingPharmaceutical
29 January 2013Statement of Organization, Functions, and Delegations of AuthorityHereAdministrativeVeterinary
30 January 2013Science Board to the Food and Drug AdministrationHereHereMeetingMeetingGeneral
31 January 2013Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and CertificationHereOMB SubmissionMedical Device
31 January 2013Medical Devices; Inspection by Accredited Persons ProgramHereOMB SubmissionMedical Device
31 January 2013Determination That DIFFERIN (Adapalene) Solution, 0.1%, Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessHereAdministrativePharmaceutical
31 January 2013Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral SclerosisHereHereMeetingMeetingGeneral
31 January 2013Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments; CorrectionHereAdministrativeGeneral
31 January 2013Determination of Regulatory Review Period for Purposes of Patent Extension; BEYAZHereAdministrativePharmaceutical
31 January 2013Determination of Regulatory Review Period for Purposes of Patent Extension; XALKORIHereAdministrativePharmaceutical
4 February 2013International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of PharmaceuticalsHereHereGuidanceGuidancePharmaceutical
4 February 2013Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment PeriodHereGuidanceGuidancePharmaceutical, Biologic
6 February 2013Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement InitiativeHereHereAdministrativePharmaceutical
6 February 2013Training Program for Regulatory Project ManagersHereHereAdministrativePharmaceutical
6 February 2013Medical Device User Fee Cover Sheet, Form FDA 3601HereAdministrativeMedical Device
6 February 2013Administrative Detention and Banned Medical DevicesHereAdministrativeMedical Device
7 February 2013Dental Devices; Reclassification of Temporary Mandibular Condyle ProsthesisHereReclassificationMedical Device
7 February 2013Request for Nominations for Voting Members on Public Advisory Panels or CommitteesHereHereMeetingMeetingMedical Device
8 February 2013Medical Devices; Ophthalmic Devices; Classification of the Eyelid WeightHereReclassificationMedical Device
8 February 2013Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually IdentifiableHereOMB SubmissionGeneral
8 February 2013Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage DiseaseHereHereGuidanceGuidancePharmaceutical
8 February 2013International Drug Scheduling; Convention on Psychotropic Substances; World Health Organization Scheduling Recommendations for Gamma-hydroxybutyric AcidHereHereAdministrativePharmaceutical
11 February 2013Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein ProductsHereHereGuidanceGuidancePharmaceutical, Biologic
11 February 2013Food and Drug Administration/Xavier University PharmaLink Conference-Quality in a Global Supply ChainHereMeetingMeetingPharmaceutical
12 February 2013Food and Drug Administration Drug Shortages Task Force and Strategic PlanHereHereAdministrativePharmaceutical
13 February 2013Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals ProcessesHereOMB SubmissionMedical Device
13 February 2013Documents To Support Submission of an Electronic Common Technical DocumentHereHereAdministrativePharmaceutical
13 February 2013Annual Computational Science Symposium; ConferenceHereMeetingMeetingPharmaceutical
13 February 2013Global Quality Systems-An Integrated Approach To Improving Medical Product SafetyHereMeetingMeetingPharmaceutical, Medical Device
15 February 2013Draft 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 IHereHereGuidanceGuidanceMedical Device
15 February 2013Guidance for Industry and Food and Drug Administration Staff: Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial FibrillationHereHereGuidanceGuidanceMedical Device
15 February 2013Circulatory System Devices Panel of the Medical Devices Advisory CommitteeHereMeetingMeetingMedical Device
15 February 2013Transmissible Spongiform Encephalopathies Advisory CommitteeHereMeetingMeetingBlood Product
19 February 2013Medical 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 CureHereHereRegulationMedical Device
19 February 2013Evaluation 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 ActHereHereOMB SubmissionPharmaceutical, Biologic
19 February 2013Draft 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 ActHereHereGuidanceGuidanceMedical Device
19 February 2013Neonatal Subcommittee of the Pediatric Advisory CommitteeHereMeetingMeetingGeneral
20 February 2013Environmental Impact ConsiderationsHereOMB SubmissionGeneral
21 February 2013Extreme Weather Effects on Medical Device Safety and QualityHereHereAdministrativeMedical Device
21 February 2013Device Good Manufacturing Practice Advisory CommitteeHereHereMeetingMeetingMedical Device
22 February 2013Draft Guidance for Industry and Food and Drug Administration Staff: Distinguishing Medical Device Recalls From Product Enhancements; Reporting RequirementsHereHereGuidanceGuidanceMedical Device
22 February 2013Determination of Regulatory Review Period for Purposes of Patent Extension; Sapien Transcatheter Heart ValveHereAdministrativeMedical Device
22 February 2013Request 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 PanelsHereHereAdministrativeGeneral
25 February 2013Fecal Microbiota for TransplantationHereHereMeetingMeetingBiologic
25 February 2013Pediatric Advisory CommitteeHereMeetingMeetingBiologic, Pharmaceutical
25 February 2013Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory CommitteeHereMeetingMeetingBiologic
25 February 2013Guidance 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 GuidanceHereGuidanceGuidanceDietary Supplement
25 February 2013Guidance for Industry on Labeling for Human Prescription Drug and Biological Products-Implementing the Physician Labeling Rule Content and Format RequirementsHereHereGuidanceGuidanceBiologic, Pharmaceutical
25 February 2013Draft 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 DataHereHereGuidanceGuidancePharmaceutical
25 February 2013Human Subject Protection; Acceptance of Data From Clinical Studies for Medical DevicesHereHereRegulationMedical Device
26 February 2013Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated ProductsHereRegulationGeneral
26 February 2013Foreign Clinical Studies Not Conducted Under an Investigational New Drug ApplicationHereOMB SubmissionPharmaceutical
26 February 2013Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood Donors and Blood and Blood Components Based on Screening Tests for SyphilisHereHereGuidanceGuidanceBlood Product
26 February 2013Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical InvestigatorsHereHereGuidanceGuidanceGeneral
26 February 2013Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source PlasmaHereHereGuidanceGuidanceBlood Product
26 February 2013Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013HereMeetingMeetingGeneral
27 February 2013Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory CommitteeHereMeetingMeetingMedical Device
27 February 2013Oncologic Drugs Advisory CommitteeHereMeetingMeetingPharmaceutical
27 February 2013Ophthalmic Devices Panel of the Medical Devices Advisory CommitteeHereMeetingMeetingMedical Device
27 February 2013Psychopharmacologic Drugs Advisory CommitteeHereMeetingMeetingPharmaceutical
27 February 2013Science Board to the Food and Drug Administration Advisory Committee; Amendment of NoticeHereMeetingMeetingGeneral
28 February 2013Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human Prescription Drug and Biological Products LabelingHereHereGuidanceGuidanceBiologic, Pharmaceutical
28 February 2013Mammography Quality Standards Act RequirementsHereOMB SubmissionMedical Device
28 February 2013Determination of Regulatory Review Period for Purposes of Patent Extension; LAVIVHereAdministrativeBiologic
28 February 2013Determination of Regulatory Review Period for Purposes of Patent Extension; ZYTIGAHereAdministrativePharmaceutical
4 March 2013Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration StaffHereHereGuidanceGuidanceMedical Device
4 March 2013Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient TransportHereRegulationMedical Device
4 March 2013Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair ElevatorHereRegulationMedical Device
4 March 2013Determination 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 EffectivenessHereAdministrativePharmaceutical
5 March 2913Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device SubmissionsHereHereGuidanceGuidanceMedical Device
5 March 2913International 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))HereGuidanceGuidanceVeterinary
5 March 2913International 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))HereGuidanceGuidanceVeterinary
6 March 2013Implementation 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;HereAdministrativeDietary Supplement
6 March 2013Cheng Yi Liang: Debarment OrderHereHereAdministrativeGeneral
6 March 2013Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal ProsthesesHereHereGuidanceGuidanceMedical Device
7 March 2013New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; NHereAdministrativeVeterinary
7 March 2013Veterinary Oversight of Antimicrobial Use in Livestock: Impact on StakeholdersHereMeetingMeetingVeterinary
7 March 2013Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug ApplicationsHereAdministrativeVeterinary
8 March 2013Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small Entity Compliance GuideHereGuidanceGuidanceDietary Supplement
8 March 2013Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk PlanHereAdministrativeBiologic, Pharmaceutical
11 March 2013Draft 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 LatexHereHereGuidanceGuidanceMedical Device
11 March 2013Drug Development for Chronic Fatigue Syndrome and Myalgic EncephalomyelitisHereHereMeetingMeetingBiologic, Pharmaceutical
12 March 2013Cellular, Tissue and Gene Therapies Advisory CommitteeHereMeetingMeetingBiologic
13 March 2013Guidance on Reagents for Detection of Specific Novel Influenza A VirusesHereOMB SubmissionBiologic
13 March 2013Cooperative Agreement To Support Regulatory Research Related to Food and Drug Administration Commitments Under the 2012 Prescription Drug User Fee ActHereHereAdministrativeBiologic, Pharmaceutical
13 March 2013Draft Guidance for Industry and Review Staff on Formal Dispute Resolution: Appeals Above the Division LevelHereHereGuidanceGuidanceBiologic, Pharmaceutical
13 March 2013Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for EvaluationHereHereGuidanceGuidancePharmaceutical
13 March 2013Food and Drug Administration/Xavier University Global Medical Device ConferenceHereMeetingMeetingMedical Device
14 March 2013Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory CommitteeHereMeetingMeetingBiologic
15 March 2013Institutional Review Boards; Correcting AmendmentsHereRegulation
15 March 2013Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood DonationsHereHereMeetingMeetingBiologic, Medical Device
18 March 2013Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump-Premarket Notification [510(k)] SubmissionsHereOMB SubmissionMedical Device
18 March 2013Center for Drug Evaluation and Research Medical Policy CouncilHereHereAdministrativeBiologic, Medical Device
18 March 2013International Conference on Harmonisation; Proposed Change to Rodent Carcinogenicity Testing of PharmaceuticalsHereAdministrativePharmaceutical
18 March 2013General and Plastic Surgery Devices Panel of the Medical Devices Advisory CommitteeHereMeetingMeetingMedical Device
18 March 2013Impax Laboratories, Inc.; Withdrawal of Approval of Bupropion Hydrochloride Extended-Release Tablets, 300 MilligramsHereHereAdministrativePharmaceutical
20 March 2013Public Hearing Before a Public Advisory Committee; Technical AmendmentsHereRegulationGeneral
20 March 2013Current Good Manufacturing Practice for Positron Emission Tomography DrugsHereOMB SubmissionPharmaceutical
21 March 2013Pulmonary-Allergy Drugs Advisory CommitteeHereMeetingMeetingPharmaceutical
21 March 2013Risk Communications Advisory CommitteeHereHereMeetingMeetingGeneral
21 March 2013Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval ApplicationsHerePMA UpdateMedical Device
22 March 2013New Animal Drugs; Changes of SponsorHereAdministrativeVeterinary
22 March 2013Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical GasesHereHereAdministrativePharmaceutical
25 March 2013New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone AcetonideHereAdministrativeVeterinary
25 March 2013Effective Date of Requirement for Premarket Approval for Automated External Defibrillator SystemHereHereRegulationMedical Device
25 March 2013Determination That BENADRYL (diphenhydramine hydrochloride) Injection and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or EffectivenessHereAdministrativePharmaceutical
25 March 2013Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Extension of Comment PeriodHereMeetingMeetingMedical Device
26 March 2013Service of Process on Manufacturers; Manufacturers Importing Electronic Products Into the United States; Agent Designation; Change of AddressHereAdministrativeMedical Device
26 March 2013Medical Devices; Technical AmendmentHereAdministrativeMedical Device
26 March 2013Food Labeling; Notification Procedures for Statements on Dietary SupplementsHereAdministrativeDietary Supplement
26 March 2013Determination 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 EffectivenessHereAdministrativePharmaceutical
26 March 2013Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; AvailabilityHereHereGuidanceGuidanceBlood Product
27 March 2013Summit on Color in Medical Imaging; Cosponsored Public Workshop; Request for CommentsHereHereMeetingMeetingMedical Device
27 March 2013Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002HereOMB SubmissionDietary Supplement
28 March 2013Guidance for Industry and Food and Drug Administration Staff: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferiHereHereGuidanceGuidanceMedical Device
29 March 2013Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal GelHereStandardsPharmaceutical
1 April 2013Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 CopolymersHereRegulationMedical Device
1 April 2013Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or ApplicantsHereHereGuidanceGuidanceBiologic
1 April 2013Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment AddendumHereGuidanceGuidancePharmaceutical
2 April 2013Change of Address; Biologics License Applications; Technical AmendmentHereAdministrativeBiologic
2 April 2013Center for Devices and Radiological Health: Experiential Learning ProgramHereHereAdministrativeMedical Device
2 April 2013Guidance for Industry and Food and Drug Administration Staff: User Fees and Refunds for Premarket Approval Applications and Device Biologics License ApplicationsHereHereGuidanceGuidanceBiologic, Medical Device
2 April 2013Implementation 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 PeriodHereAdministrativeDietary Supplement
2 April 2013International Consortium of Cardiovascular RegistriesHereHereMeetingMeetingMedical Device
2 April 2013Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting ScheduleHereMeetingMeetingMedical Device
2 April 2013Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human UseHereHereAdministrativePharmaceutical, Medical Device
2 April 2013New Animal Drugs; Enrofloxacin; Tilmicosin; TylosinHereAdministrativeVeterinary
3 April 2013Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting RequirementsHereOMB SubmissionMedical Device
3 April 2013Draft 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 11040-4HereHereGuidanceGuidanceMedical Device
3 April 2013Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug OverdoseHereReclassificationMedical Device
4 April 20132013 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference: Driving Quality and Compliance Throughout the Product Life Cycle in a Global Regulatory EnvironmentHereMeetingMeetingPharmaceutical
4 April 2013Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal FoodHereAdministrativeDietary Supplement
4 April 2013Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Amendment of NoticeHereMeetingAdministrativePharmaceutical
4 April 2013Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of MeetingHereMeetingMeetingMedical Device
4 April 2013Peripheral and Central Nervous System Drugs Advisory CommitteeHereMeetingMeetingPharmaceutical
5 April 2013Agreement for Shipment of Devices for SterilizationHereOMB SubmissionMedical Device
5 April 2013Export of Medical Devices; Foreign Letters of ApprovalHereOMB SubmissionMedical Device
5 April 20132013 Medical Countermeasures Initiative Regulatory Science SymposiumHereMeetingMeetingMedical Device
5 April 2013Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical PracticeHereMeetingMeetingGeneral
5 April 2013Vaccines and Related Biological Products Advisory CommitteeHereMeetingMeetingBiologic
5 April 2013Pediatric Device Consortia Grant ProgramHereAdministrativeMedical Device
5 April 2013Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical DevicesHereMeetingMeetingMedical Device
8 April 2013Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Investigational New Drug ApplicationsHereHereAdministrativeBiologic
8 April 2013Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence RecommendationsHereStandardsPharmaceutical
8 April 2013Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)HereHereGuidanceGuidanceBiologic, Pharmaceutical
8 April 2013Center for Devices and Radiological Health: Health of Women ProgramHereHereMeetingMeetingMedical Device
9 April 2013New Animal Drugs; Change of SponsorHereAdministrativeVeterinary
9 April 2013Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation ActHereHereAdministrativeBiologic, Pharmaceutical
9 April 2013Draft Guidance for Industry and Food and Drug Administration Staff: Molecular Diagnostic Instruments With Combined FunctionsHereHereGuidanceGuidanceMedical Device
11 April 2013Guidance for Industry on Self-Selection Studies for Nonprescription Drug ProductsHereHereGuidanceGuidancePharmaceutical
11 April 2013Guidance for Industry and Food and Drug Administration Staff: Medical Device Classification Product CodesHereHereGuidanceGuidanceMedical Device
11 April 2013Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013-2015HereHereAdministrativeBiologic, Pharmaceutical
15 April 2013International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic RiskHereHereGuidanceGuidancePharmaceutical
15 April 2013Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory CommitteeHereMeetingMeetingPharmaceutical
16 April 2013Generic Drug Facilities, Sites, and OrganizationsHereHereAdministrativePharmaceutical
16 April 2013Document to Support Submission of an Electronic Common Technical Document-Specifications for File Format Types Using Electronic Common Technical Document SpecificationsHereHereAdministrativeBiologic, Pharmaceutical
17 April 2013Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework for Preventing Cross-ContaminationHereHereGuidanceGuidancePharmaceutical
18 April 2013Determination That the OXYCONTIN (Oxycodone Hydrochloride) Drug Products Covered by New Drug Application 20-553 Were Withdrawn From Sale for Reasons of Safety or EffectivenessHereHereAdministrativePharmaceutical
18 April 2013Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome ClaimsHereOMB SubmissionBiologic, Pharmaceutical
19 April 2013Use of Certain Symbols in LabelingHereHereRegulationMedical Device
19 April 2013Clinical Laboratory Improvement Amendments Waiver ApplicationsHereOMB SubmissionGeneral
19 April 2013Electronic Submission of Medical Device Registration and ListingHereOMB SubmissionMedical Device
19 April 2013Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and CertificationHereOMB SubmissionMedical Device
19 April 2013Health Care Professional Survey of Prescription Drug PromotionHereHereOMB SubmissionBiologic, Pharmaceutical
23 April 2013Investigational Device Exemptions Reports and RecordsHereOMB SubmissionMedical Device
23 April 2013Annual Public Meeting of Reagan-Udall FoundationHereHereMeetingMeetingGeneral
23 April 2013Draft 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"HereHereGuidanceGuidanceBiologic
23 April 2013Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the Duration of the ProgramHereHereAdministrativeMedical Device
24 April 2013Protection of Human Subjects: Informed Consent; Institutional Review BoardsHereOMB SubmissionGeneral
23 April 2013Experimental Study: Examination of Corrective Direct-to-Consumer Television AdvertisingHereHereOMB SubmissionPharmaceutical
24 April 2013Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication ErrorsHereHereGuidanceGuidanceBiologic, Pharmaceutical
25 April 2013Guidance for Industry and Food and Drug Administration Staff: Assay Migration Studies for In Vitro Diagnostic DevicesHereHereGuidanceGuidanceMedical Device
25 April 2013Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory CommitteeHereMeetingMeetingMedical Device
26 April 2013Guidance for Industry on Regulatory Classification of Pharmaceutical Co-CrystalsHereHereGuidanceGuidancePharmaceutical
30 April 2013New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and TylosinHereAdministrativeVeterinary
30 April 2013Abbreviated New Animal Drug ApplicationsHereOMB SubmissionVeterinary
1 May 2013Guidance: Emergency Use Authorization of Medical ProductsHereOMB SubmissionGeneral
1 May 2013Medical Devices; Inspection by Accredited Persons ProgramHereOMB SubmissionMedical Device
1 May 2013Ashley Brandon Foyle: Debarment OrderHereAdministrativePharmaceutical
2 May 2013Product Jurisdiction: Assignment of Agency Component for Review of Premarket ApplicationsHereOMB SubmissionMedical Device
2 May 2013Gastroenterology and Urology Devices Panel of the Medical Devices Advisory CommitteeHereMeetingMeetingMedical Device
2 May 2013Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot ProgramHereHereAdministrativeBiologic, Pharmaceutical
6 May 2013Electronic Submission Process for Voluntary Complaints to the Center for Devices and Radiological HealthHereHereOMB SubmissionMedical Device
6 May 2013An Evaluation of the Prescription Drug User Fee Act Workload AdjusterHereAdministrativeBiologic, Pharmaceutical
6 May 2013Food 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 QualityHereMeetingMeetingBiologic, Pharmaceutical
8 May 2013Evaluation 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 ActHereOMB SubmissionBiologic, Pharmaceutical
8 May 2013Public Health Service Guideline on Infectious Disease Issues on XenotransplantationHereOMB SubmissionBiologic
8 May 2013David Freeman: Debarment OrderHereAdministrativePharmaceutical
8 May 2013Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood ComponentsHereHereGuidanceGuidanceBlood Product
8 May 2013510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Public MeetingHereHereMeetingMeetingMedical Device
8 May 2013Microbiology Devices Panel of the Medical Devices Advisory CommitteeHereMeetingMeetingMedical Device
9 May 2013General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp ProductsHereHereRegulationMedical Device
9 May 2013Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and AnswersHereHereGuidanceGuidanceBiologic, Pharmaceutical
9 May 2013Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use-Questions and AnswersHereHereGuidanceGuidanceBiologic, Pharmaceutical
9 May 2013Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public HearingHereHereMeetingMeetingPharmaceutical
10 May 2013Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic DrugsHereOMB SubmissionBiologic, Pharmaceutical
10 May 2013Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually IdentifiableHereOMB SubmissionMedical Device
10 May 2013Anesthetic and Analgesic Drug Products Advisory CommitteeHereMeetingBiologic, Pharmaceutical
13 May 2013New Animal Drugs; Change of Sponsor's Name and Address; Change of SponsorHereAdministrativeVeterinary
13 May 2013New Animal Drug Applications and Supporting Regulations and Form FDA 356VHereOMB SubmissionVeterinary
13 May 2013Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessHereAdministrativePharmaceutical
13 May 2013Dental Products Panel of the Medical Devices Advisory CommitteeHereMeetingMeetingMedical Device
14 May 2013Communicating Composite Scores in Direct-to-Consumer AdvertisingHereHereOMB SubmissionGeneral
14 May 2013Prescription Drug Product Labeling; Medication Guide RequirementsHereOMB SubmissionBiologic, Pharmaceutical
14 May 2013Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare DataHereHereGuidanceGuidanceBiologic, Pharmaceutical
16 May 2013Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event MarkerHereHere
16 May 2013Guidance for Industry on How To Submit Information in Electronic Format to Center for Veterinary Medicine Using the Food and Drug Administration's Electronic Submission GatewayHereOMB SubmissionVeterinary
16 May 2013Bar Code Label Requirement for Human Drug and Biological ProductsHereOMB SubmissionBiologic, Pharmaceutical
16 May 2013Postmarket SurveillanceHereOMB SubmissionMedical Device
17 May 2013Guidance for Industry and FDA Staff: Center for Devices and Radiological Health Appeals ProcessesHereHereGuidanceGuidanceMedical Device
17 May 2013Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A; Draft Guidance for Industry and Food and Drug Administration StaffHereHereGuidanceGuidanceMedical Device
17 May 2013Anesthetic and Analgesic Drug Products Advisory CommitteeHereMeetingMeetingPharmaceutical

Tags: Latest News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe