FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CBER Helping to Speed Gene Therapies: Marks

[ Price : $8.95]

CBER director Peter Marks outlines his Centers plans to speed gene therapy development, such as through FDA-encouraged harmonizati...

Opdivo sBLA for Bladder Cancer

[ Price : $8.95]

FDA accepts for priority review a Bristol Myers Squibb (BMS) supplemental BLA for Opdivo (nivolumab) for combination use with cisp...

Animal Drug Regulations Amended

[ Price : $8.95]

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions during July, August, and Se...

Industry Concerns with Predicate Device Guide

[ Price : $8.95]

Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an ...

Belmont Eyecare Selling Unapproved Eye Drops: FDA

[ Price : $8.95]

FDA warns Chicago, IL-based Belmont Eyecare it is illegally marketing six types of eye drops that are unapproved new drugs.

MONARCH 3 Results Show Verzenio Success: Lilly

[ Price : $8.95]

Lilly says that MONARCH 3 trial results indicate its Verzenio plus an aromatase inhibitor had a better survival rate than the cont...

How FDA One-stop PJOs Help Combo Industry

[ Price : $8.95]

A recent conference panel describes how FDA Product Jurisdiction Officers provide one-stop communication and coordination services...

No Safety Issues in Biosimilar Switches: CDER Research

[ Price : $8.95]

CDER researchers say their statistical analysis demonstrates that switching between biosimilars and their reference products is no...

ImmunoGen sBLA for Elahere Seeks Full Approval

[ Price : $8.95]

FDA accepts for priority review an ImmunoGen supplemental BLA to convert the accelerated approval of Elahere (mirvetuximab soravta...

Pentagon Hits FDA on Generic Testing

[ Price : $8.95]

A lengthy Bloomberg News article outlines concerns the Defense Department, health systems, and Congress have about FDAs ability to...