FDA investigators cite five GMP issues during a September inspection at Modernas primary facility in Norwood, MA, according to a Reuters report.
FDA sends Warning Letters to nine manufacturers and distributors of misbranded unapproved animal antimicrobial drugs.
FDA says it is participating in three new medical device collaborative communities.
House Energy and Commerce Committee Republicans threaten to subpoena FDA if it continues to not produce foreign drug inspection information requested ...
FDA approves an Abbott PMA for its automated GLP systems Track, which is intended to support high-volume laboratory needs and maximize productivity.
FDA approves a Medtronic PMA for the PulseSelect Pulsed Field Ablation System for treating both paroxysmal and persistent atrial fibrillation.
Federal Register notice: FDA issues an order debarring Adam Michael Nagy for a period of 15 years from importing any drug into the U.S.
A Bloomberg Law article says FDA is doing little to address potentially violative social media drug ads.
