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.
Human Drugs
Black Box Warning Added to Pfizers Xeljanz
FDA approves a Black Boxed warning about an increased risk of blood clots and death with Pfizers tofacitinib (Xeljanz, Xeljanz XR) 10 mg twice daily d...
Medical Devices
MiRus Cygnus Anterior Cervical Plate System Cleared
FDA clears a MiRus 510(k) for the Cygnus Anterior Cervical Plate System.
Human Drugs
Breakthrough Status for Arginase 1 Deficiency Candidate
FDA grants Aeglea BioTherapeutics a breakthrough therapy designation for pegzilarginase, indicated for treating Arginase 1 Deficiency.
Human Drugs
Resonea Sleep Apnea Pre-screener Cleared
FDA clears a Resonea 510(k) for the Drowzle Sleep Apnea Pre-screening Device.
Federal Register
Info Collection on Device Export Approval Letters
Federal Register notice: FDA sends to OMB an information collection extension for Export of Medical Devices; Foreign Letters of Approval.
Human Drugs
6 Observations in QuVa Pharma Inspection
FDA releases the FDA-483 with six observations issued following an inspection at the QuVa Pharma outsourcing facility.
