FDA Review posts the Federal Register notices for the week ending 4/13/2018.
FDA releases the FDA-483 detailing 12 observations from a 2017 inspection at Koreas Celltrion drug manufacturing facility.
FDA posts a guidance on Special Protocol Assessment that provides drug manufacturers with information about the procedures and policies adopted by CDE...
Federal Register notice: FDA announces a 5/1 Antimicrobial Drugs Advisory Committee meeting to discuss a Siga Technologies NDA for tecovirimat.
Federal Register notice: FDA submits for OMB approval an information collection extension for its Guidance for Industry on Formal Dispute Resolution: ...
FDA releases a final guidance on Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices.
A state court jury in New Jersey hands down a $33 million verdict against C.R. Bard in a product liability lawsuit involving its allegedly defective p...
Federal Register notice: FDA submits to OMB for approval an information collection extension for Notification of the Intent To Use An Accredited Perso...