Medical Devices
Legislation Needed to Move Away from Predicate-based 510(k)s
A JAMA viewpoint says legislation is needed to codify changes FDA is seeking to its medical device 510(k) program to reduce the reliance of equivalenc...
Human Drugs
Foamix Pharmaceuticals NDA for Rosacea Foam
Foamix Pharmaceuticals files an NDA seeking approval for FMX103 foam for treating moderate-to-severe papulopustular rosacea in patients aged 18 years ...
Federal Register
Draft Guide on Device MRI Safety
Federal Register notice: FDA makes available a draft guidance on medical device MRI-safety testing and labeling.
Human Drugs
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 8/2/2019.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 8/2/2019.
Federal Register
Nonclinical Toxicology Studies Q & A Draft Guide
Federal Register notice: FDA makes available a draft guidance entitled Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers....
Federal Register
Guide on Developing Bacterial Vaginosis Drugs
Federal Register notice: FDA releases a final guidance on bacterial vaginosis drug development.
Federal Register
Draft Guide on Clin-Pharm Considerations for Neonatals
Federal Register notice: FDA makes available a draft guidance entitled General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and...
Medical Devices
FDA Clears Medicreas Tulip Genesis Spinal Screw
FDA clears a Medicrea Group 510(k) for its Tulip Genesis for use with the UNiD Adaptive Spine Intelligence platform technology.
