An Institute for Clinical and Economic Review white paper states the potential benefits and challenges of several policy changes that could strengthen...
AdvaMed says it supports FDA efforts to expand exemptions from premarket notification for some Class 2 devices.
The Trump administration nominates former deputy surgeon general Erica Schwartz to be CDC director, and taps FDA principal deputy commissioner Sara Br...
Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, ...
FDA satellite laboratories branch director JaCinta Batson touts the value of the laboratories work in international mail facilities to stop illegal an...
CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and commitments.
FDA plans a 7/23-24 Pharmacy Compounding Advisory Committee meeting to discuss adding certain peptides to the agencys bulk drugs for compounding list....
An FDA town hall gives a detailed explanation of the new medical device Quality Management System Regulation and answers frequently asked questions ab...
