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…
Mexico creates nearshoring incentives in push for regional integration
The new package is a pillar of President Claudia Sheinbaum’s long-term plan to bolster the country’s role in North America’s…
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…
Calvin Klein owner’s cotton sourcing scrutinized by China
An ongoing investigation will determine if PVH should be added to the country’s Unreliable Entity list.
CDER Small Business & Industry Assistance (SBIA)
A Comprehensive Resource for Information on Human Drug Development in Regulation
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…
Pharmaceutical Quality Resources
FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs.
Supply chain risks persist, FDA medical device director says
Michelle Tarver flagged the U.S.’s lack of mandatory reporting requirements for potential device shortages.
FedEx, UPS discounts expected to keep rate hikes in check
Ground shipping costs are projected to drop slightly year over year in Q1, according to the TD Cowen/AFS Freight Index.