FDA issues a draft guidance to help sponsors develop fixed-dose combination hypertension drugs.
Federal Register notice: FDA extends the comment period on a draft guidance entitled Recommendations for Dual 510(k) and Clinical Laboratory Improveme...
FDA approves a Synergy Pharmaceuticals NDA for Trulance (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with consti...
A CDRH Webinar discusses reasons for a finalized guidance on how the agency categorizes IDEs to support CMS in making coverage decisions.
Endo says it will follow an FDA request that it agree to stay its suit against the agency over bulk compounding of new drugs.
Three CDRHers discuss various PMA applications for dermatology medical devices.
FDA grants Synthon Biopharmaceuticals a fast track designation for its investigational anti-HER2 antibody-drug conjugate [vic-]trastuzumab duocarmazin...
FDA grants AngioDynamics an expedited access pathway designation for its NanoKnife System and a proposed indication for use in treating Stage 3 pancre...