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)…
Post‐Mortem Hair Analysis for Novel Synthetic Opioids and Xylazine: Perspectives From Taiwan on Method Enhancement and Future Applications
Drug Testing and Analysis, EarlyView.
Hospira, Inc. Issues a Voluntary Nationwide Recall for 4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection, USP Due to the Potential for Presence of Glass Particulate Matter
Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection,…
Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations
Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations
Benefits of Emerging Technology Program (ETP)
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product…