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- 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
December 11, 2023
- What You Should Know about Eye Drops
- Drug Trials Snapshots: VABYSMO
- Final Guidance: Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements
December 8, 2023
- Drug Trials Snapshots: XENOVIEW
- Orange Book
December 7, 2023
- Drug Trials Snapshots: BRIUMVI
- Drug Trials Snapshots: VTAMA
- FDA Drug Shortages
- Omeprazole; Sodium Bicarbonate For Suspension (New - Discontinuation)
- Omeprazole; Sodium Bicarbonate Suspension (New - Discontinuation)
- Testosterone Gel, Metered (New - Discontinuation)
December 6, 2023
- Draft Guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Draft Guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Revision 2
- FDA Drug Shortages
- Amoxapine Tablet (Updated - Currently in Shortage)
- Amoxicillin Powder, For Suspension (Updated - Currently in Shortage)
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Updated - Currently in Shortage)
- Atropine Sulfate Ointment (New - Discontinuation)
- Capecitabine Tablet (Updated - Currently in Shortage)
- Carboplatin Injection (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Clonazepam Tablet (Updated - Currently in Shortage)
- Fludarabine Phosphate Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Isoniazid Tablet (Updated - Currently in Shortage)
- Methamphetamine Hydrochloride Tablet (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Tablet (Updated - Currently in Shortage)
- Methylphenidate Hydrochloride Tablet, Extended Release (Updated - Currently in Shortage)
- Nizatidine Capsule (Updated - Currently in Shortage)
- Streptozocin Powder, For Solution (Updated - Currently in Shortage)
- Sucralfate Tablet (Updated - Currently in Shortage)
- Sulfasalazine Tablet (Updated - Currently in Shortage)
December 5, 2023
- Drugs@FDA Data Files (Updated)
- FDA Drug Topics: An Overview of FDA’s Project Facilitate Oncology Expanded Access Program - December 12, 2023
- A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs
December 4, 2023
December 1, 2023
- Drug Trials Snapshots: ROLVEDON
- Drug Trials Snapshots: SPEVIGO
- FDA Drug Shortages
- Sodium Chloride 0.9% Irrigation (Updated - Currently in Shortage)
- Sterile Water Irrigant (Updated - Currently in Shortage)
November 30, 2023
- New “Q&A with FDA” Podcast: A Step Forward in the Treatment of Opioid and Alcohol Dependence with Dr. Iilun Murphy and Dr. Marta Sokolowska - now offering CE!
November 29, 2023
- Spotlight on CDER Science
- Competitive Generic Therapy Approvals (updated)
- Drug Trials Snapshots: IMJUDO
November 28, 2023
- Drugs@FDA Data Files (Updated)
- FDA Drug Safety Communication: FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
- FDA Drug Shortages
- Ketamine Hydrochloride Injection (Updated - Currently in Shortage)
- Drug Trials Snapshots: PLUVICTO
November 27, 2023
- Drug Trials Snapshots: VOQUEZNA
- Drug Trials Snapshots: ADUHELM
- Drug Trial Snapshots: AMVUTTRA
- Drug Trials Snapshots: TECVAYLI
- FDA Drug Shortages
- Alclometasone Dipropionate Cream (New - Discontinuation)
- Dulaglutide Injection (Updated - Currently in Shortage)
- Felbamate Oral Suspension (New - Discontinuation)
- Nitroglycerin Injection (Updated - Currently in Shortage)
November 24, 2023
November 22, 2023
November 21, 2023
- Drugs@FDA Data Files (Updated)
- CDER Alert: FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks
- Guidance Snapshot Pilot (Updated)
November 15, 2023
November 14, 2023
- Drugs@FDA Data Files (Updated)
- FDA Drug Shortages
- Sodium Acetate Injection (New - Currently in Shortage)
November 13, 2023
- FDA Drug Shortages
- Cisplatin Injection (Updated - Currently in Shortage)
November 9, 2023
- FDA Drug Shortages
- Cyclopentolate Hydrochloride Ophthalmic Solution (Updated - Currently in Shortage)
- Cyclopentolate Hydrochloride, Phenylephrine Hydrochloride Ophthalmic Solution (Updated - Currently in Shortage)
- Fluorescein Sodium Injection (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Orange Book
November 8, 2023
- FDA approves fruquintinib in refractory metastatic colorectal cancer
- FDA amends pembrolizumab’s gastric cancer indication
- Untitled Letters (updated)
- FDA Drug Shortages
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
November 7, 2023