FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Advisory Panel to Review Bayer Drug

[ Price : $8.95]

Federal Register notice: FDA announces an 11/16 Antimicrobial Drugs Advisory Committee meeting that will review a Bayer NDA for ci...

Guide on Advancing Emerging Technology In Drug Manufacturing

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance entitled Advancement of Emerging Technology Applications for Pharmaceutica...

Guidance on Deficiencies in Device Submissions

[ Price : $8.95]

FDA makes available a guidance on Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions.

Guide on Oncology Reproductive Toxicity Testing

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Oncology Pharmaceuticals: Reproductive Toxicity Testing and...

Comments Sought on Opioid Policy Committee

[ Price : $8.95]

Federal Register notice: FDA seeks comments or suggestions on issues relevant to the agencys newly established Opioid Policy Steer...

Aegerion Corporate Integrity Agreement Revealing: Attorneys

[ Price : $8.95]

A recent corporate integrity agreement between Aegerion Pharmaceuticals and HHS Office of Inspector General provides insights into...

FDA Clears K2M Yucon Spinal System

[ Price : $8.95]

FDA clears a K2M Group Holdings 510(k) for its Yukon Oct Spinal System, a device intended to facilitate fusion with posterior fixa...

HHS Secretary Price Resigns Amid Chartered Aircraft Scandal

[ Price : $8.95]

HHS secretary Tom Price resigns amid a furor over his use of expensive private chartered aircraft for government travel.

Divis Laboratories Inspection Observations

[ Price : $8.95]

FDA releases the FDA-483 containing six observations from an inspection at Indias Divis Laboratories.

FDA Issues Emerging Tech Application Guidance

[ Price : $8.95]

FDA finalizes a guidance to help drug companies wanting to participate in a program to include emerging technology in specified re...