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OGD Procedure for Major/Minor Amendments

[ Price : $8.95]

The Office of Generic Drugs gives chemistry reviewers a MAPP with additional information and examples on determining major and min...

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.

Whistleblower Center Looking for Drug, Medical Device Cases

[ Price : $8.95]

The Corporate Whistle Blower Center calls on people with knowledge of drug or medical device company illegal activity to come forw...

Zimmer Warning Letter on Trilogy Acetabular Manufacturing

[ Price : $8.95]

FDA sends Zimmer a Warning Letter over manufacturing and validation issues cited after an inspection at a manufacturing facility i...