FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Sen. Johnson Probing FDA Rare Disease Denials

[ Price : $8.95]

Senator Ron Johnson (R-WI) launches a congressional investigation into FDAs recent decisions to reject or delay treatments for rar...

FDA Opens New, Searchable Adverse Event Platform

[ Price : $8.95]

FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on ...

FDA OKs Bristol Myers Squibbs Sotyktu for Psoriatic Arthritis

[ Price : $8.95]

FDA approves Bristol Myers Squibs Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis.

4 Major Issues Plaguing FDA: Newsweek

[ Price : $8.95]

A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.

FDA Posts 483 Related to New Novo Nordisk Warning Letter

[ Price : $8.95]

FDA releases the Form 483 behind a 3/5 Warning Letter to Novo Nordisk that cited serious violations of postmarketing adverse drug ...

CGMP Violations in Tentamus India Inspection

[ Price : $8.95]

FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.

Advita Ortho Hit with 7 QS Violations

[ Price : $8.95]

FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equin...

Rosemont Pharma Gets Complete Response on Valacyclovir

[ Price : $8.95]

FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.

FDA Flags Safety Reporting Lapses at U.K. Clinical Trial Site

[ Price : $8.95]

FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of s...

Vertex Reports Positive Interim Phase 3 Data for Povetacicept

[ Price : $8.95]

Vertex Pharmaceuticals says an interim analysis of its Phase 3 RAINIER trial showed its experimental therapy povetacicept signific...