A Pennsylvania federal court rejects Sanofis request to dismiss a Taxotore whistleblower suit on 1st Amendment grounds.
Sidley Austin attorneys outline provisions in an FDA discussion paper on laboratory developed tests.
Federal Register Notice: FDA confirms the effective date for a final rule that appeared in the 11/1/2016 Federal Register that amended the color addit...
Federal Register Notice: FDA determines that Acthar Gel Synthetic (seractide acetate) injection, 80 units/milliliter (mL) and 40 units/mL, was withdra...
Federal Register Notice: FDA is seeking comments on an information collection extension related to Premarket Approval of Medical Devices.
A Senate Finance Committee Hearing 1/24 considers the nomination of president Trumps pick to lead HHS, House Budget Committee chair Tom Price (R-GA) a...
On his first official working day in office, president Donald Trump pledges to cut regulations by 75%, and he pulls the U.S. out of the Trans-Pacific ...
Eagle Pharmaceuticals files a 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke.