OR WAIT null SECS
September 18, 2020
The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.
September 14, 2020
The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.
September 11, 2020
In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.
September 09, 2020
PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.
September 08, 2020
Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.
September 02, 2020
The guidance recommends steps to detect and prevent nitrosamine impurities in pharmaceutical products.
The agency is reviewing an application for Dexamethasone Taw for treating adult patients with COVID-19.
The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.
The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.
August 31, 2020
Hahn promises transparency in the review and approval of COVID-19 vaccines.