FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Comments Extended on FDA Genus Notice

[ Price : $8.95]

Federal Register notice: FDA extends the comment period for the notice entitled Genus Medical Technologies LLC Versus Food and Dru...

Guide on Studying Multiple Gene Therapies

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Pr...

Guide on Gene Therapy Orphan Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Interpreting Sameness of Gene Therapy Products Under the Or...

Real-World Data Draft Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Real-World Data: Assessing Electronic Health Records and Me...

FDA Schedules Panel Meeting for More Boosters

[ Price : $8.95]

FDA announces a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting to discuss booster doses for both Mod...

Merck Seeking EUA for Covid-19 Oral Drug

[ Price : $8.95]

Merck announces its intent to seek an FDA emergency use authorization for molnupiravir, an investigational oral antiviral medicine...

Device User Fee Assessment Finds CDRH Meeting Goals

[ Price : $8.95]

A new medical device user fee program independent assessment by Booz Allen finds that even during the pandemic and an increasing w...

Bayer Recalls Lotrimin and Tinactin Products

[ Price : $8.95]

Bayer recalls all unexpired Lotrimin AF and Tinactin spray products (lot numbers beginning with TN, CV or NAA) due to the presence...

Draft Guide on Investigator Safety Reporting

[ Price : $8.95]

Federal Register notice: FDA posts a draft guidance entitled Investigator Responsibilities Safety Reporting for Investigational D...

Draft Guide on Drug Benefit-Risk Assessments

[ Price : $8.95]

Federal Register notice: FDA posts a draft guidance entitled Benefit-Risk Assessment for New Drug and Biological Products.