FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Latest Federal Register Notices

[ Price : $8.95]

FDA Review posts the Federal Register notices for the week ending 4/22/2022.

Guide on Nanomaterial in Drugs/Biologics

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Drug Products, Including Biological Products, That Contain ...

Guidance on N-Acetyl-L-Cysteine Policy

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine.

Covid-19 Vaccine Guidance Update

[ Price : $8.95]

Federal Register notice: FDA makes available an updated guidance document entitled Emergency Use Authorization for Vaccines to Pre...

Guide on 510(k) Refuse to Accept Policy

[ Price : $8.95]

FDA posts a final guidance entitled Refuse to Accept Policy for 510(k)s that outlines the procedures and criteria the agency inten...

Biogen Pulls European Submission on Alzheimers Drug

[ Price : $8.95]

Biogen withdraws a European marketing authorization application for its troubled Alzheimers drug aducanumab.

Revance BLA Resubmission Accepted for Review

[ Price : $8.95]

FDA accepts for review a Revance Therapeutics BLA resubmission for DaxibotulinumtoxinA for Injection, indicated for treating moder...

FDA Nixes 6 Outdated Compliance Policy Guides

[ Price : $8.95]

Federal Register notice: FDA withdraws six compliance policy guides because they contain duplicative information or they no longer...

Comments Sought on Electronic Drug Quality Data Submissions

[ Price : $8.95]

FDA seeks comments from the pharmaceutical industry on its project to identify and prioritize pharmaceutical quality and chemistry...

Put T-Cell Assessment in Covid-19 Vaccine Trials: Scientists

[ Price : $8.95]

More than 65 scientific experts call on FDA to recommend that Covid-19 vaccine developers assess T-cells in addition to antibodies...