Federal Register
OMB Approves 23 FDA Information Collections
Federal Register notice: FDA announces that 23 information collections have been approved by OMB.
Human Drugs
Teva Shuts Plant, Recalls Drugs Over Sterility
Teva Pharmaceuticals temporarily stops production at its Irvine, CA manufacturing facility after a recent FDA inspection cited manufacturing concerns ...
Medical Devices
Communicating Cybersecurity Best Practices
FDA posts a document entitled Best Practices for Communicating Cybersecurity Vulnerabilities to Patients.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 9/30/2021.
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 9/30/2021.
Federal Register
Real-World Data Draft Guidance
Federal Register notice: FDA makes available a draft guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data to...
Biologics
FDA Schedules Panel Meeting for More Boosters
FDA announces a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting to discuss booster doses for both Moderna and Janssen Cov...
Human Drugs
Merck Seeking EUA for Covid-19 Oral Drug
Merck announces its intent to seek an FDA emergency use authorization for molnupiravir, an investigational oral antiviral medicine that new data show ...
Medical Devices
Device User Fee Assessment Finds CDRH Meeting Goals
A new medical device user fee program independent assessment by Booz Allen finds that even during the pandemic and an increasing workload, CDRH contin...
