CDER Center for Clinical Trial Innovation (C3TI)
Enable and amplify existing and future CDER clinical trial innovation through enhanced communication and collaboration
Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support…
Division of Applied Regulatory Science
The Division of Applied Regulatory Science is located within FDA’s Office of Clinical Pharmacology and tackles emerging regulatory questions and…
Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter
Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10…
Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatment
The FDA is providing this communication to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil…
CDER Small Business and Industry Assistance (SBIA) Learn
SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small…
CDER Small Business & Industry Assistance (SBIA)
A Comprehensive Resource for Information on Human Drug Development in Regulation
Pharmaceutical Quality Resources
FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs.
Impact of Repeated Glucocorticoid Oral Administration on the Urinary Steroid Profile
The consumption of glucocorticoids does not significantly impact the steroid profile. Steroid profiles might be flagged due to glucocorticoid consumption…
Impact of Repeated Glucocorticoid Oral Administration on the Urinary Steroid Profile
The consumption of glucocorticoids does not significantly impact the steroid profile. Steroid profiles might be flagged due to glucocorticoid consumption…