Federal Register notice: FDA seeks comments on an information collection extension for Current Good Manufacturing Practice (CGMP) for Positron Emissio...
FDA issues a guidance on design of nonclinical studies to develop pharmaceuticals to treat patients with severely debilitating or life-threatening hem...
FDA releases an updated guidance on using animal-derived material in medical device manufacturing.
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Viru...
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviate...
FDA issues Pharmaceutics International two Establishment Inspection Reports following routine and pre-approval inspections last October and November a...
FDA approves Biotroniks Acticor and Rivacor high-voltage cardiac rhythm management device lines for treating patients with cardiac arrhythmias.
FDA approves a new indication for Abbott Vasculars MitraClip mitral valve clip delivery system.