FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Focus Group Info Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA sends a proposed collection of information on FDA focus groups to the Office of Management and Budget...

Pediatric Committee to Hear AER, Lactation Updates

[ Price : $8.95]

Federal Register Notice: FDAs Pediatric Advisory Committee will meet 11/27-28 to discuss adverse event reports on Tamiflu, Sereven...

Labopharm Seeks FDA Dispute Resolution on NDA

[ Price : $8.95]

Labopharm Inc. says it will seek formal dispute resolution with FDA over its concerns raised in a second approvable letter on its ...

Medtronic Pulls Faulty Defibrillator Leads

[ Price : $8.95]

Medtronic suspends sales and distribution of the Sprint Fidelis defibrillator leads due to the potential for lead fractures, which...

Pfizer Providing Sermo Content

[ Price : $8.95]

Pfizer agrees to provide online content to Sermos physician community.

Company Sues Over Test Reclassification

[ Price : $8.95]

HiFI DNA Tech says FDA and HHS should approve its petition to reclassify HPV DNA tests from Class 3 to Class 2.

FDA Guide on Dietary Supplement AE Reporting

[ Price : $8.95]

A new draft guidance for dietary supplement makers outlines adverse event reporting requirements that were mandated by last years ...

Public Workshop on Cell/Scaffold Products

[ Price : $8.95]

Federal Register Notice: CBER, CDRH, and the National Institute of Standards and Technology plan a public workshop 12/6-7 on in vi...

Noninferiority Studies Guidance Out

[ Price : $8.95]

FDA issues a guidance to explain appropriate clinical study designs to evaluate antibacterial drugs.

Europeans Look Online for Health Info

[ Price : $8.95]

A Manhattan Research white paper says drug companies should make better use of local Web sites in Europe to bring information to c...