Human Drugs
Mercks Covid Drug has 52% Risk Reduction: FDA
An FDA advisory committee briefing document says Mercks oral antiviral molnupiravir is associated with a relative risk reduction of 52% in hospitaliz...
FDA General
Latest Federal Register Notices
FDA Review posts the Federal register notices for the week ending 11/26/2021.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 11/26/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Regulatory Review Period for Immunomedics Trodelvy
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Immunomedics breast cancer therapy Trodelvy.
Medical Devices
MDR and QS Violations at Smiths Medical
FDA warns Minneapolis-based Smiths Medical about Medical Device Reporting and Quality System violations in its work as a specification developer and m...
Medical Devices
De Novo Classification Rule Webinar
FDA schedules a 12/14 Webinar on the medical device de novo classification process and its guidance document updates.
Human Drugs
Feds Say Frenchman Made False Statements to FDA
The Justice Department says a French national has been charged with making false statements to FDA to fraudulently obtain control of the weight-loss d...
Medical Devices
Pear Therapeutics Breakthrough for Alcohol-use App
FDA grants Pear Therapeutics a breakthrough device designation for its reSET-A PDT (Prescription Digital Therapeutic) product candidate designed for t...
Biologics
Multiple Violations Found in Surgenex Inspection
FDA warns Scottsdale, AZ-based Surgenex about CGMP and other violations in its production and distribution of cellular products for allogenic use.
