FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CDRH Reg Advisor Silverstein Joins Private Sector

[ Price : $8.95]

CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein leaves FDA for an undisclosed private sector job.

CGMP, Other Violations at Aire-Master of America

[ Price : $8.95]

FDA warns Nixa, MO-based Aire-Master of America about CGMP and other violations in its manufacturing of two hand sanitizers.

Shuren Advocates for More Regulatory Flexibility Post Covid

[ Price : $8.95]

CDRH director Jeff Shuren says that life after Covid-19 at the Center could greatly benefit from more regulatory flexibility, whic...

FDA Approves GSKs Measles Vaccine

[ Price : $8.95]

FDA approves a GSK BLA for Priorix (measles, mumps and rubella vaccine) for use in individuals 12 months of age and older.

Bristol Myers Withdraws sBLA for Reblozyl

[ Price : $8.95]

Bristol Myers Squibb withdraws a supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfus...

WA State Court Backs Learned Intermediary in DTC Case

[ Price : $8.95]

The Washington State Supreme Court rules that doctors, and not drug companies, bear responsibility to warn patients about potentia...

Class 1 Recall on Respironics Ventilators with Faulty Alarms

[ Price : $8.95]

FDA classifies as Class 1 a Philips Respironics recall of all V60 and V60 Plus ventilators because an internal power fluctuation m...

Guide on Device Meetings/User Fee Submissions Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws its guidance entitled Effects of the Covid-19 Public Health Emergency on Formal Meetings an...

Complete Response Letters Not for Judicial Review: Court

[ Price : $8.95]

An appeals court rules that it does not have jurisdiction to hear disputes arising from FDA complete response letters because they...

Novavax Covid Vaccine Showed Myocarditis Safety Signal: FDA

[ Price : $8.95]

FDA says Novavaxs Covid-19 vaccines two-dose primary series demonstrated significant efficacy results in clinical trials, but it a...