What's New Related to Drugs
Updated Monday through Friday
- Current and Resolved Drug Shortages and Discontinuations Reported to FDA
- 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
Updated Weekly
Updated Biweekly
January 17, 2025
January 16, 2025
- CDER Alert: FDA warns health care professionals not to use epinephrine nasal solutions from BPI Labs and Endo USA
- Webinar: Navigating Controlled Correspondences to Support Generic Drug Development
- Webinar: Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions
January 14, 2025
January 13, 2025
January 10, 2025
January 7, 2025
- Drug Trials Snapshots: ORLYNVAH
- Draft Guidance for Industry: Developing Drugs for Optical Imaging
January 6, 2025
- Draft Guidance: Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
- Final Guidance for Industry: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Final Guidance for Industry: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Final Guidance for Industry: Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers
January 3, 2025
- Workshop: Optimizing Pregnancy Registries
- Draft Guidance: Considerations for Complying with 21 CFR 211.110
December 31, 2024
- Final Guidance: Advanced Manufacturing Technologies Designation Program
December 30, 2024
- Meeting Announcement: February 24, 2025 Meeting of the Cardiovascular and Renal Drugs Advisory Committee
- July - September 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
December 27, 2024
- FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection
- Draft Guidance: Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
- Draft Guidance: E6(R3) Good Clinical Practice: Annex 2
- Draft Guidance: M15 General Principles for Model-Informed Drug Development
- Final Guidance: E11A Pediatric Extrapolation
December 26, 2024
- Public Notifications:
- CDER Statement: FDA recommends changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder
December 23, 2024
- CDER Statement: FDA issues final rule to broaden types of nonprescription drugs available to consumers
December 20, 2024
- List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
- FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation
December 19, 2024
- Joint US FDA – Health Canada ICH Public Meeting 2025
- WILDMAN may be harmful due to hidden drug ingredients
December 18, 2024
- FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in pediatric patients
- FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer
December 17, 2024