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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
November 4, 2022
- FDA Drug Shortages
- Cefazolin Injection (Updated - Currently in Shortage)
- Isoniazid Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Pentostatin Injection (Updated - Currently in Shortage)
- FDA Updates on Bebtelovimab (New)
November 3, 2022
- Competitive Generic Therapy Approvals (updated)
- Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance (Updated)
- Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (Updated)
November 2, 2022
- FDA Drug Shortages
- Butenafine Hydrochloride Cream (New - Discontinuation)
- Final Guidance Cross Labeling Oncology Drugs in Combination Regimens Guidance for Industry (Updated)
November 1, 2022
- Final Guidance: S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals
- Drugs@FDA Data Files (updated)
- Draft Guidance: Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program
- Draft Guidance: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
- FDA Drug Shortages
- Amoxicillin Oral Powder for Suspension (New - Currently in Shortage)
- Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
- Memantine Hydrochloride Extended-Release Capsules (New - Discontinuation)
October 31, 2022
- Draft Guidance: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability
- FDA Drug Shortages
- Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
- Iopromide (Ultravist) Injection (Updated - Resolved)
October 28, 2022
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
- Bacteriostatic Water for Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cytarabine Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 25% Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Pentostatin Injection (Updated - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Propofol Injectable Emulsion (Updated - Currently in Shortage)
- Sodium Acetate Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride 14.6% Injection (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Thallous Chloride TL 201 Injection (New - Discontinuation)
October 27, 2022
- Draft Guidance: Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention
- FDA Drug Shortages
- Bosentan Tablets (New - Discontinuation)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Iohexol Injection (Updated - Discontinuation)
- IV Fat Emulsion (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
- Remifentanil Injection (Updated - Currently in Shortage)
- Final Guidance: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Updated)
October 25, 2022
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Albuterol Sulfate Inhalational Solution (New - Currently in Shortage)
- Chlordiazepoxide Hydrochloride Capsules (Updated - Resolved)
- Sulfasalazine Tablets (Updated - Currently in Shortage)
October 24, 2022
- FDA Drug Shortages
- Leuprolide Acetate Injection (Updated - Resolved)
- Rationale for FDA’s Position on the Use of Cefazolin Breakpoints as a Surrogate for Determining Breakpoints for Oral Cephalosporins for the Treatment of Uncomplicated Urinary Tract Infections
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)