Study of Sex Differences in the Clinical Evaluation of Medical Products
This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific…
AKT Trading Inc. Recalls Seasoned Bamboo Shoots Because of Possible Health Risk
AKT Trading Inc of Torrance, California is recalling 120 packages of Menma Ajitsuke Prepared Bamboo Shoot Product, because it has…
Questions and Answers on Current Good Manufacturing Practices for Drugs
As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be…
Search for Regulatory References | Drugs
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
Drug Quality Sampling and Testing Programs
FDA CDER’s quality sampling and testing programs assess pharmaceutical quality after drugs are on the market.
FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult…
Hain Celestial opens fourth distribution center, doubling network capacity
The health food manufacturer expects the facility to reduce transportation time and mileage, providing fuel and maintenance savings.
HMM, ONE, Yang Ming alliance now effective, FMC says
The agreement connecting the carriers’ mainline services across major trades lanes to Asia took effect Sunday, the agency said.
FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has…
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