FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Resonea Sleep Apnea Pre-screener Cleared

[ Price : $8.95]

FDA clears a Resonea 510(k) for the Drowzle Sleep Apnea Pre-screening Device.

Info Collection on Device Export Approval Letters

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for Export of Medical Devices; Foreign Letters of Ap...

6 Observations in QuVa Pharma Inspection

[ Price : $8.95]

FDA releases the FDA-483 with six observations issued following an inspection at the QuVa Pharma outsourcing facility.

House Committee Seeks FDA Answers on Cell Products

[ Price : $8.95]

House Energy and Commerce Committee leaders ask FDA to explain its slower than expected progress with manufacturers and providers ...

Opdivo CheckMate Trial Misses Endpoint

[ Price : $8.95]

Bristol-Myers Squibb says a Phase 3 trial of its Opdivo failed to meet the primary clinical endpoint in specified lung cancer pati...

Metal Expandable Biliary Stent Guidance

[ Price : $8.95]

FDA finalizes an updated guidance on 510(k) submissions for metal expandable biliary stents.

FDA Sets Generic Drug User Fee Rates

[ Price : $8.95]

Federal Register notice: FDA sets the generic drug user fee rates for fiscal year 2020.

Info Collection on Device Export Approval Letters

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for Export of Medical Devices; Foreign Letters of Ap...

Epizyme NDA Accepted for Tazemetostat

[ Price : $8.95]

FDA accepts for priority review an Epizyme NDA seeking accelerated approval for tazemetostat, indicated for treating metastatic or...

White House Looking at Significant Drug Price Cuts

[ Price : $8.95]

Media outlets report the Trump administration is considering an executive order to tie Medicare Part D drug prices to lower prices...