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Updated Monday through Friday
- CDER Launches New Accelerating Rare disease Cures (ARC) Program
- Drug Firm Annual Registration Status
- Drug Firm Annual Registration Status Download File
- National Drug Code Directory
- NDC Unfinished Drugs Excluded Database File
- NDC Database Excluded Packages and Products
- Wholesale Distributor and Third-Party Logistics Providers Reporting
October 21, 2022
- Upcoming Product-Specific Guidances for Complex Generic Drug Product Development (updated)
- FDA issues final guidance about multiple endpoints in clinical trials (new)
- FDA Drug Competition Action Plan (Updated)
- Draft Guidance: In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs
- Draft Guidance: In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs
- Draft Guidance: Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs
- Draft Guidance: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
October 20, 2022
- Competitive Generic Therapy Approvals (updated)
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Iomeprol Injection (Updated - Currently in Shortage)
- Final Guidance: Multiple Endpoints in Clinical Trials (updated)
October 19, 2022
- Webinar: FDA Clinical Investigator Training Course (CITC) 2022
- Advancing Real-World Evidence Program
October 18, 2022
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Alprostadil (Muse) Suppository (New - Currently in Shortage)
- Fludarabine Phosphate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Verteporfin (Visudyne) Injection (New - Currently in Shortage)
October 17, 2022
- Orange Book
- Orange Book Current Cumulative Supplement (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
- Orange Book Data Files (compressed) (updated)
- Reference Listed Drugs by ANDA Reference Standard List (updated)
- Orange Book Patent Listing Dispute List (updated)
- Appendix A: Product Name Index (updated)
- Appendix B: Product Name Sorted by Applicant (updated)
- Appendix C: Uniform Terms (updated)
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October 13, 2022
- FDA Health Playbook (updated with "Don't Get Burned" PSA)
- Final Guidance: Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
October 12, 2022
October 11, 2022
- Drugs@FDA Data Files (updated)
- Generic Drugs Program Activities Report - Monthly Performance (updated)
October 5, 2022
- Conference: Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions
- FDA Drug Shortages
- Amoxapine Tablets (Updated - Currently in Shortage)
- Diflunisal Tablets (Updated - Currently in Shortage)
- Etomidate Injection (New - Currently in Shortage)
- Fluvoxamine ER Capsules (Updated - Currently in Shortage)
- Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
- Sulfasalazine Tablets (Updated - Currently in Shortage)
- Guidance for Industry: Competitive Generic Therapies
- Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
October 4, 2022
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Fluorescein Injection (Updated - Currently in Shortage)
- Isoniazid Injection (Updated - Currently in Shortage)
October 3, 2022
- FDA Expands CDER NextGen Portal (new)
- Patent Certifications and Suitability Petitions (updated)
- Biosimilars | Science and Research (new)
- Rare Disease Endpoint Advancement Pilot Program (new)
- Split Real Time Application Review (STAR) (new)
- GDUFA III Reauthorization
- Facility Readiness: Goal Date Decisions Under GDUFA (new draft guidance)
- Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA (new draft guidance)
- FDA Drug Shortages
- Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
- Fludarabine Phosphate Injection (New - Currently in Shortage)
- Isoniazid Injection (Updated - Currently in Shortage)
- Leuprolide Acetate Injection (Updated - Currently in Shortage)
- Oxytocin Injection (Updated - Currently in Shortage)
- Semaglutide (Ozempic) Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Final Guidance: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
- Generic Drugs Program Activities Report - Monthly Performance (updated)
- PDUFA VI: Fiscal Years 2018 - 2022 (updated)
- Assessment in Support of Sentinel System (new)
- Food and Drug Administration Overdose Prevention Framework (updated)
September 30, 2022
- Competitive Generic Therapy Approvals (updated)
September 29, 2022
- The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
- FDA approves first treatment for prurigo nodularis
September 28, 2022
- FDA Drug Shortages
- Cefazolin Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 10% Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Efavirenz Capsules (New - Discontinuation)
- Etomidate Injection (Updated - Resolved)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Ibutilide Fumarate Injection (Updated - Currently in Shortage)
- IV Fat Emulsion (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Remifentanil Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
September 27, 2022
- Drugs@FDA Data Files (updated)
- Guidance for Industry: Providing Over-the-Counter Monograph Submissions in Electronic Format
September 23, 2022
- FDA Drug Shortages
- Oxytocin Injection (New - Currently in Shortage)
September 22, 2022
- FDA Drug Shortages
- Vecuronium Bromide for Injection (Currently in Shortage)
- Guidance for Industry: Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry
September 21, 2022
- FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
- FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer
- FDA Drug Shortages
- Febuxostat Tablets (New - Discontinuation)
- Guidance for Industry: How To Obtain a Covered Product Authorization