Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 4/22/2022.
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 4/22/2022.
Federal Register
Guide on Nanomaterial in Drugs/Biologics
Federal Register notice: FDA makes available a final guidance entitled Drug Products, Including Biological Products, That Contain Nanomaterials.
Federal Register
Guidance on N-Acetyl-L-Cysteine Policy
Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine.
Federal Register
Covid-19 Vaccine Guidance Update
Federal Register notice: FDA makes available an updated guidance document entitled Emergency Use Authorization for Vaccines to Prevent Covid19 (Update...
Medical Devices
Guide on 510(k) Refuse to Accept Policy
FDA posts a final guidance entitled Refuse to Accept Policy for 510(k)s that outlines the procedures and criteria the agency intends to use in assessi...
Human Drugs
Biogen Pulls European Submission on Alzheimers Drug
Biogen withdraws a European marketing authorization application for its troubled Alzheimers drug aducanumab.
Human Drugs
Revance BLA Resubmission Accepted for Review
FDA accepts for review a Revance Therapeutics BLA resubmission for DaxibotulinumtoxinA for Injection, indicated for treating moderate to severe glabel...
Federal Register
FDA Nixes 6 Outdated Compliance Policy Guides
Federal Register notice: FDA withdraws six compliance policy guides because they contain duplicative information or they no longer reflects the agency...
