Federal Register notice: FDA issues an order granting special termination of the debarment involving Sanyasi Raju Kalidindi.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Deciphera Pharmaceuticals Qinlock (ripretinib),...
FDA issues a close-out letter citing resolved GMP issues at Zhejiang Huahai Pharmaceutical Co., Zhejiang, China, an active pharmaceutical ingredient m...
HHS withdraws a Trump Administration policy that directed FDA not to enforce premarket review requirements for laboratory developed tests.
FDA posts a revised guidance entitled Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency.
FDA Review posts product approval summaries for the week ending 11/12/2021.
Baxter Healthcare recalls its PrisMax System Version 2, a high permeability hemodialysis device, due to a software design error.