FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guide on Device Inspection Feedback

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance on nonbinding feedback after a medical device inspection.

OMHHE Marks 10th Anniversary

[ Price : $8.95]

FDA associate commissioner for minority health Richardae Araojo reviews progress made in the last years by the Office of Minority ...

Mallinckrodt NDA Hepatorenal Syndrome Type 1

[ Price : $8.95]

FDA accepts for review a Mallinckrodt NDA for terlipressin, indicated for treating hepatorenal syndrome type 1.

FDA OKs Trodelvy for Triple-negative Breast Cancer

[ Price : $8.95]

FDA approves an Immunomedics BLA for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with triple-negative metast...

CDRH Posts Ventilator EUA Template

[ Price : $8.95]

FDA posts a ventilator interactive review template for use by those seeking an emergency use authorization.

Comments on FDA Revised Immunotoxic Potential Guidance

[ Price : $8.95]

Three stakeholders suggest changes to an FDA revised draft guidance on nonclinical safety evaluation of drugs and biologics immuno...

Comments on FDA Bridging Draft Guidance

[ Price : $8.95]

Three stakeholders give general and specific comments on an FDA draft bridging guidance for combination products.

Former Commissioner Donald Kennedy Dead at 88

[ Price : $8.95]

Former FDA commissioner Donald Kennedy (1977-1979) dies due to Covid-19 at the age of 88.

Biogen Alzheimers BLA Filing Delayed

[ Price : $8.95]

Biogen says it is delaying a BLA for aducanumab, a potential treatment for Alzheimers disease that it is developing in collaborati...

Hahn Briefs House Committee on Covid-19 Efforts

[ Price : $8.95]

FDA commissioner Stephen Hahn provides a teleconference briefing to House Energy and Commerce Committee members on the agencys res...