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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
August 14, 2023
- FDA Drug Shortages
- Cisplatin Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Oxytocin Injection (Updated - Resolved)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
August 11, 2023
- Orange Book
August 10, 2023
- Webinar: Understanding FDA Inspections and Data
- 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials
- FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma
- CDER Conversation: FDA works through ICH to support global drug development: creating harmonized technical standards through guidelines
- FDA Drug Shortages
August 9, 2023
- ClinicalTrials.gov – a Three-Part Series
- Medication Health Fraud (Updated)
- Medication Health Fraud for Specific Diseases and Conditions
- FDA Actions to Stop Medication Health Fraud
- Medication Health Fraud Questions and Answers
- Public Notification: Vegetal Vigra 200mg contains hidden drug ingredient
- FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions
- FDA Drug Shortages
- Bumetanide Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Carboplatin Injection (Updated - Currently in Shortage)
- Chloramphenicol Sodium Succinate Injection (Updated - Currently in Shortage)
- Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Dacarbazine Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Gentamicin Sulfate Injection (Updated - Currently in Shortage)
- Glipizide XL Tablets (New - Discontinuation)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
August 8, 2023
- Drugs@FDA Data Files (updated)
August 7, 2023
- CDERLearn Training and Education (updated)
August 4, 2023
August 3, 2023
- Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act
- Drug Trials Snapshots: FEXINIDAZOLE
- Drug Trials Snapshots: NEXTSTELLIS
- Drug Trials Snapshots: ZEGALOGUE
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Azacitidine for Injection (New - Discontinuation)
- Azacitidine for Injection (Updated - Currently in Shortage)
- Difluprednate Ophthalmic Emulsion (Updated - Currently in Shortage)
- Linezolid Tablets (New - Discontinuation)
- Triamcinolone Acetonide Injectable Suspension (Updated - Currently in Shortage)
August 2, 2023
- Draft Guidance for Industry: Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief
- FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer
- FDA Drug Shortages
- Leucovorin Calcium Injection (Updated - Currently in Shortage)
- Methylphenidate Hydrochloride Extended Release Tablets (Updated - Currently in Shortage)
- Tirzepatide Injection (Updated - Currently in Shortage)
August 1, 2023
- Drugs@FDA Data Files (updated)
- CDER Conversation: Improving Medication Adherence and Patient Experience by Researching Patient Perceptions of Generic Drug
- FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness
- FDA Drug Shortages
- Bupivacaine Hydrochloride Injection (Updated - Discontinuation)
- Diclofenac Sodium Topical Gel (New - Discontinuation)
- Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage)
- Isoniazid Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Pramipexole Dihydrochloride Extended Release Tablets (New - Discontinuation)
July 31, 2023
July 28, 2023
- Conference/Workshop - Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023
- CDER collaborates with global regulators on pharmaceutical quality assessments and inspections
- FDA Drug Shortages
- Cisplatin Injection (Updated - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
July 27, 2023
- Competitive Generic Therapy Approvals (updated)
- Drug Trials Snapshots: QULIPTA
- FDA Drug Shortages
- Indigotindisulfonate Sodium Injection (Updated - Currently in Shortage)
July 26, 2023
- Final Guidance: CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
- Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (updated)
- Prescription Stimulant Medications
- FDA Drug Shortages
- Methylphenidate Hydrochloride Extended Release Tablets (New - Currently in Shortage)
July 25, 2023
- Drugs@FDA Data Files (updated)
July 24, 2023
- Event - OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
- Event - Advancing Generic Drug Development: Translating Science to Approval 2023
- CURE ID, A Tool for Clinicians to Report New Uses of Existing Drugs with Heather Stone and Dr. Marco Schito
- FDA Drug Shortages
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Fluorescein Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Methotrexate Tablets (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
July 21, 2023
- Drug Trials Snapshots: LEQVIO
- FDA Drug Shortages
- Beclomethasone Dipropionate Monohydrate Nasal Spray (New - Discontinuation)
- Lidocaine Hydrochloride (Xylocaine) Injection (New - Currently in Shortage)
- Methamphetamine Hydrochloride Tablets (Updated - Currently in Shortage)
- Methotrexate Tablets (New - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
July 20, 2023
- Drug Trials Snapshots: ZYNLONTA
- FDA Drug Shortages
- Furosemide Injection (Updated - Currently in Shortage)
- Metronidazole Injection (Updated - Currently in Shortage)
July 19, 2023
- FDA Drug Shortages
- Carboplatin Injection (New - Currently in Shortage)
July 18, 2023
- Drugs@FDA Data Files (updated)
- GDUFA Implementation Quarterly Meetings between FDA and Industry (updated)
- Competitive Generic Therapy Approvals
- Drug Trials Snapshots: SAPHNELO
- FDA Drug Shortages
- Amino Acids (Updated - Currently in Shortage)
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Lorazepam Injection (New - Discontinuation)
July 17, 2023
- FDA Drug Shortages
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Novel Drug Approvals for 2023 (updated)
July 14, 2023
- FDA Drug Shortages
- Lisdexamfetamine Dimesylate Capsules (New - Currently in Shortage)
- 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)