FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Ex-Sebelius Aide Purges FDA Press Office

[ Price : $8.95]

In an unprecedented purging of career staff under her, new FDA associate commissioner for external affairs Beth Martino, 31, remov...

FDA Panel Backs Fecal Incontinence PMA

[ Price : $8.95]

FDA's Gastroenterology and Urology Devices Panel votes to recommend approval of an Oceana Therapeutics PMA for Solesta, a bulking ...

Reviewers Raise Safety Concerns on Orexigen Weight-loss NDA

[ Price : $8.95]

FDA reviewers say there are cardiovascular safety concerns associated with the potential approval of Orexigen's proposed weight-lo...

Comments Sought on Indexing Unapproved Animal Drugs

[ Price : $8.95]

Federal Register Notice; FDA seeks comments on indexing legally marketed unapproved new animal drugs for minor species.

Comments Sought on Indexing Approved Animal Drugs

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on indexing legally marketed new animal drugs for minor species.

Info on Clinical Efficacy in Labeling Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA sends a proposed collection of information on a study of clinical efficacy information in professiona...

Q&A Guidance on Residual Solvents in Animal Drugs

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance answering questions on CVMs implementation of USP residual solvents in anim...

FDA Clears MedPro Safety Blood Collection Kit

[ Price : $8.95]

FDA clears a MedPro Safety Products 510(k) for its passive-safety winged blood collection set.

FDA Clears Medtronic Spinal System for Scoliosis

[ Price : $8.95]

FDA clears a Medtronic 510(k) for its CD Horizon Spinal System and its use in treating adolescent idiopathic scoliosis.

FDA Denies Osmotica Venlafaxine Petition

[ Price : $8.95]

FDA denies an Osmotica citizen petition asking the agency not to approve ANDAs for generic forms of its venlafaxine HCl unless the...