FDA General
Latest Federal Register Notices
FDA Review posts the latest Federal Register notices for the week ending 7/30/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Device User Fee Rates for FY 2022
Federal Register notice: FDA has set the medical device user fee rates for fiscal year 2022.
Federal Register
Antimicrobial Panel to Discuss Takeda NDA
Federal Register notice: FDA announces a 10/7 Antimicrobial Drugs Advisory Committee meeting to discuss Takeda's maribivir.
Federal Register
Biologic Samples/Protocols Requests Extension
Federal Register notice: FDA sends to OMB an information collection extension entitled Request for Samples and Protocols.
Human Drugs
Regen-Cov EUA Expanded to Preventing Covid
FDA revises Regenerons emergency use authorization for Regen-Cov (casirivimab and imdevimab), expanding its emergency use as post-exposure prevention ...
Medical Devices
FDA Dismisses JAMA Report on Misclassified Death Reports
FDA dismisses concerns raised in a JAMA Internal Medicine report that many medical device adverse event reports involving a patient death are misclass...
Medical Devices
TransMedics OCS Lung Solution Cleared for Cold Temp
FDA clears a TransMedics Group 510(k) for its OCS Lung Solution for use in transplants using cold storage techniques.
Human Drugs
GSKs Nucala Approved for Nasal Polyps
FDA approves GlaxoSmithKlines Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosi...
Federal Register
eCTD Validations Effective 9/15: FDA
Federal Register notice: CDER and CBER announce the effective date of 9/15 for using Electronic Common Technical Document validations referenced in FD...
