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General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp ProductsFDARulemaking
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Biosimilar User Fee ActFDANonrulemaking
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Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public DocketFDARulemaking
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Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic ActFDARulemaking
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Requests that the FDA abandon the "customarily consumed" and/or the "majority rules" benchmarks for determining nutritional data on food labels and require all food manufacturers to adhere to 100% truthful uniformity in providing nutritional data to consumers.FDANonrulemaking
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Petitioner requests that the U.S. Food and Drug Administration’s (“FDA”) Center for Devices and Radiological Health (“CDRH”) withdraw approval of Premarket Approval Number P140018 for the VenaSeal® Closure System (“VenaSeal®”).FDANonrulemaking
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Variance Request for Glare RecoilFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic ActFDANonrulemaking
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International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS)FDANonrulemaking
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Questions and Answers Regarding Drug and Device Manufacturer Communications with Payors; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Reference Amounts Customarily Consumed: List of Products for Each Product CategoryFDANonrulemaking
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Patent Extension Application for XTAMPZA® U.S. Patent No. 8,449,909FDANonrulemaking
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Patent Extension Application for XTAMPZA® U.S. Patent No. 7,399,488FDANonrulemaking
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Patent Extension Application for XTAMPZA® U.S. Patent No 7,771 ,707FDANonrulemaking
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Mallinckrodt Pharmaceuticals; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate TabletsFDANonrulemaking
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Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate TabletsFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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Variance Request from ChristieFDANonrulemaking
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Laser Light ShowFDANonrulemaking
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How to Prepare a Pre-Request for Designation (Pre-RFD); AvailabilityFDANonrulemaking
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Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11--Questions and Answers; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Child-Resistant Packaging Statements in Drug Product LabelingFDANonrulemaking
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Modified Risk Tobacco Product Applications: Applications for IQOS System with Marlboro Heatsticks, IQOS System with Marlboro Smooth Menthol Heatsticks, and IQOS System with Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.FDANonrulemaking
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Breakthrough Devices ProgramFDANonrulemaking
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Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous UseFDANonrulemaking
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Expedited Programs for Regenerative Medicine Therapies for Serious ConditionsFDANonrulemaking
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Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act ProductsFDANonrulemaking
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Clinical and Patient Decision Support SoftwareFDANonrulemaking
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Drug Products Labeled as HomeopathicFDANonrulemaking
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Providing Comments on CDER Level 2 GuidancesFDANonrulemaking
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Patent Extension Application for Diamondback 360® U.S. Patent No. 9,055,966FDANonrulemaking
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Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic ActFDANonrulemaking
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Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by FDAFDANonrulemaking
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Requests that the FDA stay and reconsider the Final Rule on Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food EstablishmentsFDANonrulemaking
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Request that the Commissioner of Food and Drugs amend the sulfite warning requirement in 21 C.F.R. 201.22 for sulfite-containing epinephrine for injection for use in emergency situations, in order to remove misleading information and acknowledge the current availability of approved epinephrine products that do not contain sulfite.FDANonrulemaking
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Vegetable Oil and Reduced Risk of Coronary Heart DiseaseFDANonrulemaking
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Requests that the FDA establish a specific protocol for increased surveillance, investigation and enforcement of potential Facial Misbranding violations under the Gluten-Free Labeling Rule.FDANonrulemaking
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Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Food for AnimalsFDANonrulemaking
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Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff, and Foreign GovernmentsFDANonrulemaking
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Data Integrity and Compliance With Drug CGMP: Questions and Answers; Guidance for Industry; AvailabilityFDANonrulemaking
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Postapproval Pregnancy Safety Studies; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Abbreviated New Drug Application Submissions--Amendments and Requests for Final Approval to Tentatively Approved Abbreviated New Drug Applications; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format; Companion to Direct Final Rule.FDANonrulemaking
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Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review VouchersFDANonrulemaking
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Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser and Ultrasonic Products (proposed rule)FDARulemaking
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List of Bulk Drug Substances That May be Used to Compound Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for NominationsFDANonrulemaking
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Requests that the FDA immediately require the addition of boxed warnings, warning, preacautions, and highlights of prescribing information to the product label for all selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor products, including branded and generic formulations to warn of serious and severe risks.FDANonrulemaking
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