FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

U.S. Generally Fastest in New Drug Launches

[ Price : $8.95]

An HHS-funded RAND study finds that many new drugs are available in the U.S. before launching in other countries.

Baxter Debarment Reduced by 3 Years

[ Price : $8.95]

Federal Register notice: FDA issues an order to reduce a five-year debarment against former Indivior global medical director Timot...

Supreme Court Could Hit FDA Regulation: FDLI

[ Price : $8.95]

A detailed FDLI analysis looks at how expected Supreme Court changes to the Chevron federal agency deference principle will likely...

Priority Review Granted for Galactosemia NDA

[ Price : $8.95]

FDA accepts for priority review an Applied Therapeutics NDA for AT-007 (govorestat) for treating classic Galactosemia.

Marks Sees Breakout Year in Gene Therapy Approvals

[ Price : $8.95]

CBER director Peter Marks says he expects 2024 to be a big year for gene therapy approvals as several Center initiatives take hold...

Questions on Topical Ophthalmic Draft Guide

[ Price : $8.95]

Four stakeholders update comments on the latest version of an FDA draft guidance on topical ophthalmic products.

Significant CGMP Violations at Amman Pharmaceutical

[ Price : $8.95]

FDA warns Amman, Jordan-based Amman Pharmaceutical Industries about CGMP violations in its production of drugs as a contract manuf...

FDA Cant Locate UK Maker of Filthy Eye Drops

[ Price : $8.95]

FDA fails to locate the UK-based manufacturer of filthy eye drops, LightEyez, accused of manufacturing and distributing unapproved...

FDA Warns 2 Ophthalmic Drug Companies

[ Price : $8.95]

FDA warns Mamaroneck, NY-based Delsam Pharma, and Lakewood, NJ-based EzriCare about distributing adulterated and misbranded ophtha...

FDA Denies BI Parenteral Drug Petition

[ Price : $8.95]

FDA denies a Boehringer Ingelheim petition asking it to change its interpretation of strength for parenteral solutions under the B...