FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

HHS Inspector General Will Look at REMS Implementation

[ Price : $8.95]

The HHS Inspector General lists five FDA activities it will examine in its FY 2013 work plan.

Docket Open on Sodium Nitroprusside Pediatric Studies

[ Price : $8.95]

Federal Register Notice: FDA will open a public docket to make available a report on the pediatric studies of sodium nitroprusside...

CDER Hosts Clinical Investigator Training

[ Price : $8.95]

CDER and Duke University Office of Continuing Medical Education co-sponsor a three-day training course for clinical investigators ...

Ethicon Recalls Numerous Thrombin Lots

[ Price : $8.95]

Ethicon recalls numerous lots of thrombin due to a manufacturing process deviation that may have led to decreased potency in some ...

Dietary Supplement Claims Dont Meet FDA Requirements

[ Price : $8.95]

The HHS Inspector General says FDA should seek legal authority to review manufacturer substantiation for dietary supplement struct...

Alere Agrees to FDA-requested Tighter Release Specs

[ Price : $8.95]

Alere Inc. says it has agreed to FDA-requested tighter release specifications for the companys Triage meter-based products.

Mallinckrodt Wants Exalgo ANDA Limits

[ Price : $8.95]

Mallinckrodt asks FDA to require specific bioequivalence measures for any generic form of its Exalgo.

Extend Marketing Exclusivity for Some Drug Combinations?

[ Price : $8.95]

Reps. Bilbray, Maloney, and DeLauro introduce legislation to provide additional exclusivity for drugs designated by FDA as signifi...

FDA Withdraws Approval of NADA, 3 ANADAs

[ Price : $8.95]

Federal Register Final rule: FDA amends the animal drug regulations to withdraw approval of one NADA and three ANADAs because they...

CDER Plans Clinical Investigator Training Course

[ Price : $8.95]

Federal Register Notice: CDER will co-sponsor a training course 11/13-15 for clinical investigators in College Park, MD.