Dockets

Recently active federal rulemakings, soonest-closing first.

• Requests that the FDA Warn Women About the Unknown and Inadequately Studied Effect of FDA-Regulated Mesh Devices, Implanted Off-Label in Cosmetic Mastopexy (So-Called “Internal-Bra") Operations, On the Sensitivity of Standard Surveillance Mammography and Ultrasound for Detection of Breast Cancer.FDANonrulemaking
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• 75‐Day Premarket Notification for New Dietary Ingredients_2022FDANonrulemaking
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• Laser Light ShowFDANonrulemaking
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• Laser Light ShowFDANonrulemaking
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• Laser Light ShowFDANonrulemaking
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• Phytolon Ltd; Filing of Color Additive PetitionFDARulemaking
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• GNT USA, LLC; Filing of Color Additive PetitionFDANonrulemaking
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• E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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• Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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• Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients; Draft Guidance for Industry; AvailabilityFDARulemaking
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• Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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• Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Frequently Asked Questions – Cellular and Gene Therapy Products; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFDANonrulemaking
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• Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment RequestFDANonrulemaking
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• M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry; AvailabilityFDANonrulemaking
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• Patent Term Extension Application for WaveWriter Alpha® Spinal Cord Stimulator System, Patent No. 7,437,193FDANonrulemaking
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• Patent Term Extension Application for VYJUVEK (beremagene geperpavec-svdt), Patent No. 9,877,990FDANonrulemaking
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• Patent Term Extension Application for BEYFORTUS (nirsevimab-alip), Patent No. 10,689,437FDANonrulemaking
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• Patent Term Extension Application for BEYFORTUS (nirsevimab-alip), Patent No. 11,186,628FDANonrulemaking
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• Patent Term Extension Application for BEYFORTUS® (nirsevimab-alip), Patent No. 11,661,449FDANonrulemaking
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• Patent Term Extension Application for SKINVIVE by Juvederm, Patent No. 11,260,015FDANonrulemaking
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• Patent Term Extension Application for LITFULO™ (ritlecitinib), Patent No. 9,617,258FDANonrulemaking
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• Patent Term Extension Application for EPKINLY (epcoritamab-bysp), Patent No. 10,544,220FDANonrulemaking
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• Patent Term Extension Application for EPKINLY (epcoritamab-bysp), Patent No. 10,465,006FDANonrulemaking
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• Patent Term Extension Application for SOHONOS (palovarotene), Patent No. 10,292,954FDANonrulemaking
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• Patent Term Extension Application for SOHONOS (palovarotene), Patent No. 11,622,959FDANonrulemaking
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• Patent Term Extension Application for SOHONOS (palovarotene), Patent No. 10,864,194FDANonrulemaking
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• Patent Term Extension Application for SOHONOS (palovarotene), Patent No. 9,314,439FDANonrulemaking
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• Patent Term Extension Application for EXXUA (gepirone), Patent No. 7,538,116FDANonrulemaking
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• Patent Term Extension Application for NGENLA (somatrogon-ghla), Patent No. 7,553,941FDANonrulemaking
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• Patent Term Extension Application for NGENLA (somatrogon-ghla), Patent No. 11,197,915FDANonrulemaking
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• Patent Term Extension Application for NGENLA (somatrogon-ghla), Patent No. 8,304,386FDANonrulemaking
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• Patent Term Extension Application for ELREXFIO (elranatamab-bcmm), Patent No. 9,969,809FDANonrulemaking
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• Patent Term Extension Application for ELREXFIO (elranatamab-bcmm), Patent No. 11,155,630FDANonrulemaking
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• Patent Term Extension Application for VYJUVEK (beremagene geperpavec-svdt), Patent No. 10,155,016FDANonrulemaking
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• Patent Term Extension Application for VOWST (fecal microbiota spores, live-brpk), Patent No. 9,011,834FDANonrulemaking
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• Patent Term Extension Application for VOWST (fecal microbiota spores, live-brpk), Patent No. 9,446,080FDANonrulemaking
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• Patent Term Extension Application for VOWST (fecal microbiota spores, live-brpk), Patent No. 9,180,147FDANonrulemaking
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