Medical News Update
- Human Drug Compounding Policies and Rules
- Complex Generics News
- M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
- Generic Drug User Fee Amendments
- Ongoing | Cancer Accelerated Approvals
- Generic Drug Facilities, Sites and Organization Lists
- What's New Related to Drugs
- Oncology (Cancer)/Hematologic Malignancies Approval Notifications
- FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer
- Patient Voice in Rare Disease Medical Product Development - 10/16/2026
- FDA-TRACK: Expanded Access (Compassionate Use) Submission Data
- CDER Leadership Bios
- Over-The-Counter Monograph Drug User Fee Program (OMUFA)
- Drugs@FDA Data Files
- Historical Status of OTC Rulemakings
- Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates
- Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA
- Competitive Generic Therapy Approvals
- Novel Drug Approvals for 2026
- Registered Outsourcing Facilities