FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CGMP API Deviations at Hikal Limited

[ Price : $8.95]

FDA warns Jigani, Karnataka, India-based Hikal Limited about CGMP deviations in its production of active pharmaceutical ingredient...

Issues in 3 Trials Conducted by Detroit Doctor

[ Price : $8.95]

FDA warns Detroit, MI-based medical oncologist Shirish Gadgeel about bioresearch monitoring violations in his conduct of three cli...

Former CBER Therapeutics Deputy Anatol Joins Lilly

[ Price : $8.95]

Eli Lilly hires former CBER Office of Therapeutic Products (OTP) deputy director Rachael Anatol, who was removed from her agency p...

Lexicon Submits New Data on Stalled Diabetes Drug

[ Price : $8.95]

Lexicon Pharmaceuticals submits new clinical data to FDA that attempts to advance its stalled NDA for its diabetes drug Zynquist (...

Capricor Posts Bytreldo CRL Response

[ Price : $8.95]

Capricor Therapeutics posts its response to an FDA complete response letter for Bytreldo since the agency published the letter pub...

NRx Petitions FDA to Ban Preservative in Ketamine

[ Price : $8.95]

NRx Pharmaceuticals petitions FDA seeking a ban on all ketamine products formulated with the preservative benzethonium chloride, a...

7th Circuit Backs Dismissal of AbbVie False Claims Suit

[ Price : $8.95]

The 7th Circuit Court of Appeals affirms, although for different legal reasons, a federal district court ruling rejecting a False ...

FDA Seeks Comments on Pregnant Women in Trials

[ Price : $8.95]

FDA reminds companies and the public that they have until 9/19 to submit comments on a draft guidance entitled E21 Inclusion of Pr...

Microbot Single-Use Robotic Endovascular System Cleared

[ Price : $8.95]

FDA clears a Microbot Medical 510(k) for its Liberty Endovascular Robotic System, a single-use, remotely operated device for perip...

MAHA Reports Aims to Improve Kids Health

[ Price : $8.95]

A MAHA Commission report assessing the health of American children suggests a couple of ways in which FDA could improve the situat...