FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Diabetes Drugs Riskiest to Develop: Tufts Study

[ Price : $8.95]

A Tufts Center for the Study of Drug Development analysis says that FDA review time for diabetes drugs has increased in recent yea...

CDRH Sets 10 Regulatory Science Priorities

[ Price : $8.95]

CDRH publishes 10 regulatory science priorities that will be its focus in FY 2017.

Roundabout Causation in Failure-to-Report Claims: Attorney

[ Price : $8.95]

Reed Smith attorney James Beck reviews cases that explore the legal issues in proving causation in state-law product liability ina...

Lawyers Discuss FDA Bias Concern on Chantix Study

[ Price : $8.95]

Hogan Lovells attorneys say that a CDER briefing document raises a concern that data from a Chantix post-marketing study were comp...

FDA Clears Life Spines Cervical Spacer

[ Price : $8.95]

FDA clears a Life Spine 510(k) for the PRO-LINK Ti Stand-Alone Cervical Spacer System, a stand-alone cervical interbody that is ma...

FDA Accepts Puma NDA for Breast Cancer Therapy

[ Price : $8.95]

FDA accepts for review a Puma Biotechnology NDA for its lead product candidate PB272 (neratinib), indicated for the extended adjuv...

Risk Communication Advisory Panel to Review Strategic Plan

[ Price : $8.95]

Federal Register Notice: FDAs Risk Communication Advisory Committee meets 11/ to discuss and make recommendations on the agencys d...

FDA Announce Naloxone Mobile App Competition

[ Price : $8.95]

Federal Register Notice: FDA announces the 2016 FDA Naloxone App Competition, a prize competition designed to help reduce deaths a...

Woodcock Wanted Drug Approved Before Review Completed: FDA Records

[ Price : $8.95]

A summary of an internal CDER dispute surrounding the approval of Sareptas controversial Duchenne drug Exondys 51 shows that Cente...

FDA Draft Guide on Determining When REMS is Necessary

[ Price : $8.95]

FDA posts a draft guidance on FDAs Application of Statutory Factors in Determining When a REMS Is Necessary.