What's New Related to Drugs
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
Updated Biweekly
September 11, 2024
September 10, 2024
- Drugs@FDA Data Files (Updated)
- CDER Conversation: Streamlining Drug Development and Improving Patient Care: CDER Quantitative Medicine Center of Excellence
September 6, 2024
September 5, 2024
- CDER Alert: FDA warns consumers not to purchase or use Umary and Amazy products as they may be harmful to your health
September 4, 2024
- Final Guidance: Control of Nitrosamine Impurities in Human Drugs
- Patent Certifications and Suitability Petitions (updated)
September 3, 2024
- Drugs@FDA Data Files (Updated)
August 30, 2024
- Event: October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee
- Event: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee
- Event: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products
- Drugs@FDA Data Files (Updated)
August 26, 2024
- FDA Drug Shortages
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Indocyanine Green Injection (Updated - Currently in Shortage)
- Meeting: Advancing Treatments for Post-Traumatic Stress Disorder (PTSD)
August 23, 2024
- Drug Trials Snapshots: VEOZAH
- Drug Trials Snapshots: VELSIPITY
- FDA Drug Shortages
- Indocyanine Green Injection (New - Currently in Shortage)
- Real-World Data and Evidence Generation with Dr. Hilary Marston
August 22, 2024
- Drug Trials Snapshots: PIASKY
- Upcoming Product-Specific Guidances for Generic Drug Product Development (Updated)
August 21, 2024
- FDA Drug Shortages
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product (Updated)
- Webinar: Global IDMP Implementation - Getting Closer to the Goal
August 20, 2024
- Drugs@FDA Data Files (Updated)
- FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer
- FDA Drug Shortages
- Cyclosporine Solution (New - Discontinuation)
- Webinar: ICH M12 Drug-Drug Interaction Studies Final Guidance
August 19, 2024
August 16, 2024
August 15, 2024
August 14, 2024
- FDA approves axatilimab-csfr for chronic graft-versus-host disease
- 9 Things to Know about CDER’s Efforts on Rare Diseases
August 13, 2024
- Drugs@FDA Data Files (Updated)
- Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (updated)
August 12, 2024
August 9, 2024
- Orange Book
- Approved Drug Products with Therapeutic Equivalence Evaluations
- 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)
August 7, 2024
- First Generic Drug Approvals (Updated)
- FDA Drug Shortages
- Memantine Hydrochloride Capsule, Extended Release (New - Discontinuation)
- Generic Drugs Program Monthly and Quarterly Activities Report (Updated)