Updated Monday through Friday

• 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 27, 2023

• CDER Alert: FDA requires updates to labeling for promethazine hydrochloride injection products
• Draft Guidance: Quality Considerations for Topical Ophthalmic Drug Products
• Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

December 26, 2023

• Drugs@FDA Data Files (Updated)
• Public Notifications:
  • Wild Bull contains hidden drug ingredient
  • TO THE MOON contains hidden drug ingredient
  • Schwinnng contains hidden drug ingredient
  • T XTRA Strength Test Booster contains hidden drug ingredient
  • Sustain® contains hidden drug ingredients
  • Ram It contains hidden drug ingredient

December 22, 2023

• Final Guidance: Rare Diseases: Considerations for the Development of Drugs and Biological Products
• Final Guidance: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers

December 21, 2023

• CDER Statement: FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain
• Public Notification: Govvi WOW! contains hidden drug ingredient
• Final Guidance: Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
• Final Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
• Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development
• Draft Guidance for Industry: Master Protocols for Drug and Biological Product Development

December 20, 2023

• Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful
• Final Guidance: Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization

December 19, 2023

• Drugs@FDA Data Files (Updated)

December 18, 2023

• Competitive Generic Therapy Approvals (Updated)
• Update on In-Person Face-to-Face Formal Meetings with FDA (Updated)

December 15, 2023

• FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer
• First Generic Drug Approvals (Updated)

December 14, 2023

• FDA approves belzutifan for advanced renal cell carcinoma

December 13, 2023

• Drug Trials Snapshots: TERLIVAZ
• FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma
• FDA Drug Shortages
  • Somatropin Injection (Updated - Currently in Shortage)

December 12, 2023

• Drug Trials Snapshots: RELYVRIO
• Drugs@FDA Data Files (Updated)
• Draft Guidance: Advanced Manufacturing Technologies Designation Program
• FDA Creates New Advisory Committee for Evaluation of Genetic Metabolic Disease Treatments

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
  • 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)

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

• Drug Trials Snapshots: SUNLENCA

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)