Federal Register Notice: FDA seeks comments on a new direct-to-consumer study proposal submitted to OMB for approval on Superimposed Text in DTC Promo...
Federal Register Notice: FDA extends the comment period on a 9/14 notice on the establishment of appropriately targeted durations of use of antimicrob...
Federal Register Notice: FDA announces a 3/15/2017 Pharmaceutical Science and Clinical Pharmacology Advisory Committee that will discuss the use of mo...
FDA posts a guidance on Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal E...
Federal Register Final Rule: FDA issues a final rule to establish requirements for the electronic filing of entries of FDA-regulated products in the A...
FDA releases a guidance on Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) that de...
The U.S. House of Representatives schedules an 11/30 floor vote on a revised 21st Century Cures bill that includes $6.3 billion in additional funding ...
FDA partially approves a Teva petition that sought tighter bioequivalence on generic copies of its skeletal muscle relaxant Amrix (cyclobenzaprine hyd...