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...
FDA alerts health care professionals about a recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in s...
Federal Register notice: FDA makes available a guidance entitled E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Popul...
Federal Register notice: FDA withdraws approval of 18 ANDAs from multiple applicants.