FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Microport Ortho Recall Profemur Hip Prosthesis

[ Price : $8.95]

MicroPort Orthopedics begins a Class 1 recall of the Profemur Plus Cocr Modular Neck orthopedic hip prosthesis component due to an...

Tighten Animal Drug Compounding Oversight: GAO

[ Price : $8.95]

A new Government Accountability Office report recommends that FDA improve its oversight of drug compounding for animal use.

Court Affirms Most of Shire Vyvanse Decision

[ Price : $8.95]

A federal appeals court backs a lower court decision on two key elements in a case involving disputed patents for Shires Vyvanse.

Many Devices Exposed to Online Hacking: Report

[ Price : $8.95]

UK researchers say many healthcare organizations are exposed to cyber hacking of their medical device systems.

FDA Accepts Sanofi NDA for New Diabetes Drug

[ Price : $8.95]

FDA accepts for filing a Sanofi NDA for lixisenatide, an investigational once-daily prandial GLP-1 receptor agonist for treating a...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Medsource, New Dawn Nutrition, Specialty Medicine Compounding, and Ultroid Techn...

Guidance on Generic Drug Correspondence with FDA

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Controlled Correspondence Related to Generic Drug Development.

ICH Guidance on Good Clinical Practice

[ Price : $8.95]

Federal Register Notice: FDA releases an ICH guidance: E6(R2) Good Clinical Practice.

FDA Posts Approved PMAs

[ Price : $8.95]

Federal Register Notice: FDA publishes a list of 13 PMAs that have been approved including safety and effectiveness summaries.

FDA Issues Priority Review for Xuriden

[ Price : $8.95]

Federal Register Notice: FDA issues a priority review voucher to Wellstat Therapeutics for the pediatric disease product applicati...