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Latest posts
Last updated about 2 hours ago
ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements
about 2 hours ago
GDUFA III includes several enhancements to the ANDA assessment process to maximize...
Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data - 09/18/2025
about 3 hours ago
On September 18 and 19, 2025, the U.S. Food and Drug Administration...
Apitoria Pharma Private Limited Unit 1 - 618091 - 11/13/2025
about 5 hours ago
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Aurobindo Pharmaceutical Limited - 618091 - 01/12/2022
about 5 hours ago
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
CDER Small Business and Industry Assistance (SBIA) Learn
about 9 hours ago
SBIA Learn offers a variety of multimedia resources to provide information that...
Generic Competition and Drug Prices
about 10 hours ago
FDA report demonstrating greater competition among generic drug makers can lead to...
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
3 days ago
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended...
FDA approves first interchangeable biosimilar to Perjeta to treat certain types of breast cancer
4 days ago
FDA approves first interchangeable biosimilar to Perjeta to treat certain types of...
FDA approves new interchangeable biosimilar to Perjeta
4 days ago
On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb...
FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation
4 days ago
On November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti...
Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection--Virtual Public Workshop - 05/07/2024
5 days ago
The Food and Drug Administration is holding a public, two-day workshop entitled...