Medical Devices
Draft Guide on Cybersecurity for Legacy Devices
The International Medical Device Regulators Forum (IMDRF), of which FDA is a member, seeks comments on a proposed guidance entitled Principles and Pra...
Biologics
FDA Not Delaying Pediatric Covid Vaccines: Marks
CBER director Peter Marks tells a House briefing that FDA is not delaying its review of Modernas Covid-19 vaccine for children under five years old so...
Human Drugs
LogicBio Clinical Hold Lifted by FDA
FDA lifts a clinical hold on LogicBio Therapeutics Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with methylmalonic acidemia...
Federal Register
Latest Federal Register Notices
FDA Review posts the the Federal Register notices for the week ending 5/6/2022.
Human Drugs
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 5/6/2022.
Federal Register
Info Collection on Investigational Device Exemptions
Federal Register notice: FDA seeks comments on an information collection extension entitled Investigational Device Exemptions 21 CFR Part 812.
Medical Devices
Device Guidance on Voluntary Improvement Program
FDA releases a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.
Human Drugs
Myovant, Pfizer Myfembree sNDA Review Extended
Citing the need to assess just-submitted bone mineral density data, FDA extends its review of a Myovant Sciences and Pfizer supplemental NDA for Myfem...
Federal Register
Diabetes Device Feasibility Studies Guidance
Federal Register notice: FDA makes available a final guidance entitled Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices ...
