FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Publishes Modifications to Recognized Standards

[ Price : $8.95]

Federal Register Notice: FDA releases the Modifications to the List of Recognized Standards.

FDA Clinical Hold on VaxGens Anthrax Vaccine

[ Price : $8.95]

FDA orders a clinical hold on an upcoming VaxGen Phase 2 clinical trial on its investigational anthrax vaccine rPA102 due to vacci...

NDA Submitted for Acromegaly Drug

[ Price : $8.95]

Ipsen submits an NDA for Somatuline Autogel for injection, indicated for treating patients with acromegaly.

CDRH Wants PDF for Pre-Market e-Copies

[ Price : $8.95]

CDRH releases questions and answers to issues regarding submitting electronic copies of paper pre-market submissions.

FDA Posts Four More Cyber Letters

[ Price : $8.95]

FDA releases four new cyber letters to Web site operators suspected of selling prescription drugs illegally.

Comments Sought on Animal Drug Studies

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on effectiveness studies for new animal drugs.

Comment Sought on BLA Licensing

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on general licensing provisions for BLAs, changes to an approved application, labeling...

Panel to Hear Research Updates

[ Price : $8.95]

Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 11/20 to hear updates of various re...

FDA OKs IVX Animal Health Preanesthetic

[ Price : $8.95]

Federal Register Final rule: FDA approves an IVX Animal Health ANADA for use of glycopyrrolate solution as an preanesthetic agents...

Report Sees Tougher Drug Approval Era at FDA

[ Price : $8.95]

A new analysis of FDA drug approval data suggests a toughening review climate, while CDER new drugs director John Jenkins concedes...