Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions – 03/13/2025
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions
Prescription Drug User Fee Amendments
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from…
UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee – 12/04/2024
This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak…
Global Trends and Methodological Challenges in Hair Toxicology: A Survey‐Based Analysis
Drug Testing and Analysis, EarlyView.
Biology and Management of Male‐Bodied Athletes in Elite Female Sports
Graphical representation of the relationships of transgender and XY DSDF as male-bodied athletes along the binary dimensions of biological sex.…
Jobs at CDER Frequently Asked Questions
Frequently Asked Questions about GDUFA Hiring Initiative
POSTPONED – Optimizing Pregnancy Registries – 03/27/2025
Public workshop is part of FDA’s commitment to advance optimal approaches to efficient generation of high-quality human safety data for…
Pathways for Students and Recent Graduates
Pathways for Students and Recent Graduates
Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act – 05/15/2025
Section 508 of PL 112-144 (FDASIA) requires FDA to obtain recommendations and relevant information from interested parties on the required…
Ongoing | Cancer Accelerated Approvals
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s)…