FDA issues a safety alert on hand sanitizers manufactured by Eskbiochem SA de CV in Mexico due to the potential presence of methanol (wood alcohol).
Senators Bob Casey (D-PA) and Susan Collins (R-ME) introduce the Creating Hope Reauthorization Act (S 4010) that would permanently reauthorize FDAs pe...
FDA Review posts product approval summaries for the week ending 6/21/2020.
FDA approves the expansion of a USGI Medical pilot study of it obesity-treating endoscopic procedure known as POSE 2.0.
Mylan says it is urging FDA to speed up its review of the companys ANDA for a generic copy of Biogens multiple sclerosis (MS) drug Tecfidera (dimethyl...
FDA posts a guidance entitled Good Manufacturing Practice Considerations for Responding to Covid-19 Infection in Employees in Drug and Biological Prod...
Federal Register notice: FDA announces a 7/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting that will review a GlaxoSmithKline BL...
Federal Register notice: FDA corrects a 2/12/2019 notice that announced the withdrawal of approval of 12 ANDAs from multiple applicants.