Human Drugs
First Pharma Cited for GMPs on Form 483
FDA posts a Form 483 after inspecting First Pharma Associates in Spokane, WA last month.
Medical Devices
Intersect Ent PMA Approved for Sinus Implant Delivery
FDA approves an Intersect Ent PMA for its Straight Delivery System for use in placing its Propel Mini steroid-releasing implant in the ethmoid sinus.
Federal Register
Fortamet Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that Andrx Labs Fortamet (metformin hydrochloride) extended-release tablets was not withdrawn from sale for sa...
Human Drugs
Draft Guide on Pediatric Disease Priority Vouchers
FDA issues a revised draft guide on Rare Pediatric Disease Priority Review Vouchers.
Human Drugs
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 7/26/2019.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 7/26/2019.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Guide on Kidney Transplant Delayed Graft Function
FDA posts a guidance entitled Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.
Federal Register
Metal Expandable Biliary Stents Guide
Federal Register notice: FDA makes available a final guidance entitled Metal Expandable Biliary Stents Premarket Notification (510(k) Submissions.
Human Drugs
Drug Pricing Bill Advances in Senate
The Senate Finance Committee votes 19-9 to advance the Prescription Drug Pricing Reduction Act.
