Federal Register notice: CDER seeks comments on a proposed Analysis Data Reviewers Guide (ADRG) template that was developed under an ongoing collabora...
The Better Business Bureaus National Advertising Division says Synergy Pharmaceuticals declined to participate in a self-regulatory proceeding to reso...
A Tufts Center for the Study of Drug Development company survey finds that use of real-world evidence is increasing and will grow even more in the nex...
Stericycles third quarter 2017 recall index says medical device recalls fell, while drug recalls increased.
Federal Register notice: FDA makes available a guidance on Recurrent Herpes Labialis (RHL): Developing Drugs for Treatment and Prevention.
Federal Register notice: FDA submits to OMB a new proposed information collection supporting its Draft Guidance for Industry and Review Staff on Targe...
Federal Register notice: FDA seeks comments on an information collection revision for its Guidance for Industry on Expedited Programs for Serious Cond...
FDA says it has investigated two adverse event results from a United Pharmacy compounded glutamine, arginine, and carnitine product.