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

October 27, 2023

• FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection

October 26, 2023

• Drug Trials Snapshot: LYTGOBI
• FDA Drug Shortages
  • Carboplatin Injection (New - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Clofarabine Injection (New - Discontinuation)
  • Fulvestrant Solution (New - Discontinuation)
  • Vinblastine Sulfate Injection (Updated - Currently in Shortage)
• Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products

October 25, 2023

• Draft Guidance: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
• Drug Trials Snapshot: LUNSUMIO
• Draft Guidance: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
• FDA Drug Shortages
  • Lutetium Lu-177 Vipivotide Tetraxetan Injection (Updated - Resolved)
  • Mesalamine Capsule, Delayed Release (New - Discontinuation)

October 24, 2023

• Drugs@FDA Data Files (Updated)
• Drug Trial Snapshots: ELAHERE
• FDA Drug Shortages
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Dacarbazine Injection (New - Currently in Shortage)

October 23, 2023

• Draft Guidance: Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers

October 20, 2023

• FDA expands pediatric indication for entrectinib and approves new pellet formulation

October 19, 2023

• FDA Drug Shortages
  • Cisplatin Injection (Updated - Currently in Shortage)
• Drug Trial Snapshots: CYTALUX
• Public Notification: The Rock contains hidden drug ingredient

October 17, 2023

• FDA Drug Shortages
  • Colestipol Hydrochloride Granule (New - Discontinuation)
  • Technetium Tc-99m Sodium Pertechnetate Generator (New - Discontinuation)
• Toward Global IDMP Implementation: A Focus on Global Use Cases
• CDER soliciting comments regarding clinical trial innovation
• Drugs@FDA Data Files (Updated)
• Competitive Generic Therapy Approvals (updated)

October 16, 2023

• A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Workshop
• Draft Guidance: Diabetic Foot Infections: Developing Drugs for Treatment
• Final Guidance: Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
• FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer

October 13, 2023

• Event: FDA Clinical Investigator Training Course (CITC) 2023
• FDA Drug Shortages
  • Streptozocin Powder, For Solution (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)
• iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) (Updated)

October 12, 2023

• Drug Trials Snapshots: ENJAYMO
• Draft Guidance: Quality Considerations for Topical Ophthalmic Drug Products
• FDA Drug Shortages
  • Neomycin Sulfate Tablet (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Tirzepatide Injection (Updated - Currently in Shortage)

October 11, 2023

• FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation
• FDA Drug Shortages
  • Difluprednate Emulsion (Updated- Currently in Shortage)

October 10, 2023

• Drugs@FDA Data Files (Updated)
• FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders

October 6, 2023

• FDA Drug Shortages
  • Nitroglycerin Injectable (New - Currently in Shortage)

October 4, 2023

• Drug Trials Snapshot: LIVMARLI
• Drug Trials Snapshot: BYLVAY
• CDER Takes Measures to Tackle Stimulant Use Disorder
• Draft Guidance: Stimulant Use Disorders: Developing Drugs for Treatment
• FDA Drug Shortages
  • LISDEXAMFETAMINE DIMESYLATE CAPSULE (Updated - Currently in Shortage)

October 3, 2023

• Drugs@FDA Data Files (Updated)
• FDA Drug Shortages
  • Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Lisdexamfetamine Dimesylate Capsule (Updated - Currently in Shortage)
  • Lisdexamfetamine Dimesylate Tablet, Chewable (Updatd - Currently in Shortage)

October 2, 2023

• Drug Trials Snapshots: ZTALMY
• FDA Drug Shortages
  • Leucovorin Calcium Injection (Updated - Currently in Shortage)
  • Remifentanil Hydrochloride Injection, Powder, Lyophilized, For Solution (Updated - Currently in Shortage)

September 29, 2023

• Generic Competition and Drug Prices (updated)
• FDA Drug Shortages
  • Cyclosporine Injection (New - Discontinuation)
• Final Guidance: Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”
• Public Notifications:
  • Reumo Flex contains hidden drug ingredient
  • Kuka Flex Forte contains hidden drug ingredient

September 27, 2023

• Drug Trials Snapshots: KORSUVA
• FDA Drug Shortages
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Potassium Chloride Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection (Updated - Currently in Shortage)