Reps. Upton and DeGette introduce their bipartisan Cures 2.0 legislation to create an Advanced Research Projects Agency-Health to work on cures and tr...
PhRMA and Deloitte release a report with strategies for increasing clinical trial diversity.
CBER sends NYC Regenerative Medicine an untitled letter over its Web site and Facebook page that markets its cellular product derived from human umbil...
FDA posts a revised guidance entitled Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency.
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.