FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Permanently Debars Huda

[ Price : $8.95]

Federal Register Notice: FDA issues an order permanently debarring Syed Huda from providing services to anyone with an approved or...

Bill to Speed Rare Disease Drugs

[ Price : $8.95]

Sens. Bennet, Burr, Warren, and Hatch introduce legislation to help speed development of targeted drugs for patients with serious ...

Mixed Reaction on Califf Nomination as FDA Head

[ Price : $8.95]

President Obamas nomination of Robert Califf as the next FDA commissioners receives mixed reactions from several groups, with some...

FDA Denies 3M Metered Dose Inhaler Petition

[ Price : $8.95]

FDA denies a 3M petition asking that albuterol sulfate actuators be embossed or labeled to indicate they are only to be used with ...

FDA Accepts Scilex NDA for Lidocaine Patch

[ Price : $8.95]

FDA accepts for review a Scilex Pharmaceuticals 505(b)(2) NDA for ZTlido (lidocaine patch 1.8%), indicated for treating postherpet...

New Zealands Jaychem Has CGMP Problems

[ Price : $8.95]

FDA warns New Zealands Jaychem Industries about CGMP violations and misbranding of some of its products.

CGMP Problems in Indias Pan Drugs

[ Price : $8.95]

FDA warns Pan Drugs about CGMP violations at its Vandodara, India, API manufacturing facility.

NME Review Program Meeting Goals: Comments

[ Price : $8.95]

PhRMA and BIO say that a PDUFA 5 program to improve transparency and communication in reviewing NDAs and BLAs with new molecular e...

FDA Accepts CardioFocus PMA for Heart Ablation Device

[ Price : $8.95]

FDA accepts for review a CardioFocus PMA for the HeartLight Endoscopic Ablation System for treating atrial fibrillation.

FDA Changing Clozapine Requirements

[ Price : $8.95]

FDA announces drug safety changes for clozapine labeling involving monitoring for neutropenia and a new shared REMS.