FDA releases its latest batch of Warning Letters that include The Delano Co. and Mylan Pharmaceuticals.
Six drug company stakeholders ask FDA for changes to an agency draft guidance on post-approval changes to drug substances.
Hyman, Phelps & McNamara asks FDA not to approve a Zelnorm sNDA without substantial evidence of safety and efficacy under currently applicable standar...
Synaptive Medical recalls its BrightMatter Guide with SurfaceTrace Registration due to a software defect that could potentially result in serious or l...
FDA warns Mylan about CGMP violations at its Morgantown, WV, drug manufacturing facility.
FDA places a clinical hold on a Zafgen clinical trial of ZGN-1061, the companys second-generation, investigational MetAP2 inhibitor currently in devel...
FDA releases a discussion document on patient engagement in the medical device clinical trial process as a follow-up to its 10/2017 Patient Engagement...
FDA says it is examining ways to modernize the medical device 510(k) process by relying more on a review that weighs new technologies that improve dev...