FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Panel Backs JN.1 Variant-Targeted Covid Vaccine

[ Price : $8.95]

An FDA advisory committee unanimously votes to recommend that Covid-19 vaccine makers formulate their upcoming fall shots to provi...

Amgen: Positive Data on Uplizna in Ig G4 Disease

[ Price : $8.95]

Amgen announces positive data from its Phase 3 clinical trial (MITIGATE) evaluating the efficacy and safety of Uplizna (inebilizum...

Streamline and Update Biosimilar Development: Council

[ Price : $8.95]

The Biosimilars Council calls on FDA to eliminate unnecessary clinical efficacy studies as part of streamlining the biosimilar dev...

BIMO Processes and Practices Guidance

[ Price : $8.95]

FDA publishes a draft guidance on processes and practices for Bioresearch Monitoring inspections.

Jiangsu Hengrui Inspection Nets 8-item 483

[ Price : $8.95]

A January FDA inspection at Jiangsu Hengrui Pharmaceuticals in Jiangsu, China, leads to an eight-observation Form FDA-483 that cit...

23 No-Longer-Marketed NDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws 23 NDAs from multiple applicants after being notified by the application holders that the p...

Info Collection on Device Recall Authority

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Recall Authority 21 CF...

FDA Promoting Pragmatic Clinical Research: Califf

[ Price : $8.95]

FDA commissioner Robert Califf and two colleagues make the case for so-called pragmatic clinical research using real-world evidenc...

BMS Reports Positive Opdivo plus Yervoy Data

[ Price : $8.95]

Bristol Myers Squibb reports favorable data from a Phase 3 trial evaluating the dual immunotherapy combination of Opdivo (nivoluma...

Multiple QS Issues in Techlem Inspection

[ Price : $8.95]

FDA warns Mississauga, Canada-based Techlem Medical Corporation about Quality System violations in its manufacture of misbranded w...