FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Stakeholders Comment on Patient Preference Guide

[ Price : $8.95]

Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total pro...

Furosemide Injection sNDA Faces Submission Delay

[ Price : $8.95]

scPharmaceuticals says a planned supplemental NDA submission of an autoinjector as an alternative to the current on-body infusor u...

FDA Science Board Renewed for 2 Years

[ Price : $8.95]

Federal Register notice: FDA announces the renewal of its Science Board for an additional two years.

CDER Wants AI Use in Drug Safety: Attorneys

[ Price : $8.95]

Troutman Pepper attorneys explain the potential benefits in FDAs new Emerging Drug Safety Technology Program.

Advisory Panel to Discuss Pediatric RSV Vaccine Safety

[ Price : $8.95]

FDA plans to ask its Vaccines and Related Biological Products Advisory Committee to discuss potential safety concerns related to p...

NIH Ends Mpox Study Early

[ Price : $8.95]

The National Institutes of Health ends a trial of an mpox antiviral drug that failed to produce an efficacy signal.

FDA Revokes EUAs for B.Braun Covid Devices

[ Price : $8.95]

Federal Register notice: FDA announces the revocation of B. Braun Medical emergency use authorizations for three Covid-related dev...

Regulating AI in Healthcare: Paragon White Paper

[ Price : $8.95]

A Paragon Health Institute white paper suggests an approach to regulating healthcare artificial intelligence that it says builds o...

NeuroSense Gets FDA Agreement for ALS Study

[ Price : $8.95]

Based on FDA feedback, NeuroSense Therapeutics says it will begin a Phase 3 study of PrimeC (ciprofloxacin and celecoxib) for trea...