FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Senator Urges Uniform Drug Pedigree to Prevent Shortages

[ Price : $8.95]

U.S. Senator Michael Bennet (D-CO) urges FDA to implement a uniform pedigree standard that would allow the FDA to efficiently moni...

Senate FDA Appropriations Bill Seeks $50 Million Boost

[ Price : $8.95]

The Senate Appropriations Committee approves an FDA FY 2012 proposed budget that includes about a $50 million (2%) increase over F...

NORD Asks for Orphan Drug Review Policy

[ Price : $8.95]

The National Organization for Rare Disorders petitions FDA for a policy statement on orphan drug review.

FDA Approves Sagent's Generic Haldol

[ Price : $8.95]

FDA approves a Sagent Pharmaceuticals ANDA for haloperidol injection, a generic copy of Ortho-McNeil's antipsychotic Haldol.

CBER Says Fluzone Detail Aid is False, Misleading

[ Price : $8.95]

CBERs Advertising and Promotional Labeling Branch says that a Sanofi Pasteur Fluzone detail aid omits and minimizes important risk...

Comments Sought on Humanitarian Use Device Requirements

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on the information collection requirements for humanitarian use devices.

Panel to Discuss Guillain-Barre, Adult Vaccines

[ Price : $8.95]

Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 11/16 to discuss Guillain-Barr...

FDA Staff Discuss Ventilator Alarms in Journal

[ Price : $8.95]

Three CDRH staff members give steps for reducing preventable ventilator alarm errors in a nursing journal.

Leo Asks Dovonex ANDA Restrictions

[ Price : $8.95]

Leo Pharma asks FDA to require applicants for generic Dovonex to perform specific tests before their ANDA can be approved.

New Medical Device Reviewer Training Programs Out

[ Price : $8.95]

FDA announces two new staff training programs for medical device reviewers that it says will improve their consistency.