FDAer Leah Christl says biosimilar approvals will increase over time.
FDA announces availability of a revised draft guidance on quality considerations for inhalation aerosol products.
FDA warns the UKs McCallum Manufacturing about CGMP violations in its production of finished pharmaceuticals.
FDA approves a Sientra PMA supplement allowing commercialization of its Opus-branded breast implant products manufactured by Vesta, a Lubrizol LifeSci...
A 50-member organization of environmental, public health and childrens rights groups calls on FDA to act in line with the rest of the federal governme...
Sen. Charles Grassley asks HHS and FDA for information on a Florida stem cell clinic that conducted an unapproved clinical trial in which three patien...
FDA medical reviewers say they see a positive risk-benefit profile in GW Pharmas cannabdiol for treating two specific seiure syndromes in patients ove...
Federal Register notice: FDA makes available a guidance entitled Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic D...