FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Aadi NDA for Rare Sarcoma Drug

[ Price : $8.95]

FDA accepts for priority review an Aadi Bioscience NDA for its nanoparticle albumin-bound mTOR inhibitor Fyarro for treating advan...

Webinar Explains Device Remanufacturing Draft Guidance

[ Price : $8.95]

FDA holds a Webinar to clarify agency thinking on the distinction between medical device servicing and remanufacturing and to cons...

FY 2022 Biosimilar User Fee Rates Set

[ Price : $8.95]

Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2022.

Info Collection on Medical Device Reporting

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Reporting 21 CFR Part 803....

Animal Drug User Fee Rates Set

[ Price : $8.95]

Federal Register notice: FDA announces the animal drug user fee rates and payment procedures for fiscal year 2022.

FDA Wants mRNA Vaccines Tested in More Kids

[ Price : $8.95]

FDA asks Pfizer and Moderna to expand vaccine tests in children under age 11 to better understand the risk for heart muscle inflam...

FDA Approves Mercks Keytruda for Some Breast Cancers

[ Price : $8.95]

FDA approves a 30th indication for Mercks Keytruda, this time for use with chemotherapy in some breast cancers before and after su...

FDA Clears LifeSignals ECG Remote Patch Platform

[ Price : $8.95]

FDA gives 510(k) clearance to LifeSignals Groups LifeSignals ECH remote monitoring patch platform to detect common cardiac arrhyth...

FDA Will Meet with Petros on Stendra Labeling

[ Price : $8.95]

FDA will meet with Petros over proposed labeling changes for the companys Stendra erectile dysfunction medicine.

FDA Approves Sol-Gels Twyneo Acne Treatment

[ Price : $8.95]

FDA approves Sol-Gel Technologies acne medication Twyneo that uses a patented technology to stabilize one of the active ingredient...