FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Feedback Sought on Model-Informed Drug Development

[ Price : $8.95]

CDER and CBER seek input to help advance the agencys model-informed drug development program.

FDA Authorizes Updated Novavax Covid Vaccine

[ Price : $8.95]

FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently ...

Emergent Bio Wins Mpox Vaccine Approval

[ Price : $8.95]

FDA approves an Emergent BioSolutions supplemental BLA for an expanded indication ACAM2000, (smallpox and mpox vaccine, live) to i...

FDA Backs CellProthera Cell Therapy Phase 3 Study

[ Price : $8.95]

CellProthera says a recent FDA meeting led to their alignment on a planned pivotal Phase 3 trial design for its ProtheraCytes cell...

Technical Modification for Device Malfunction Reporting

[ Price : $8.95]

Federal Register notice: FDA announces a minor technical modification to an alternative option that permits quarterly manufacturer...

Device Malfunction Summary Reporting Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for ...

J&J Files BLA for Myasthenia Gravis Therapy

[ Price : $8.95]

Johnson & Johnson files a BLA for nipocalimab, indicated for treating people living with generalized myasthenia gravis.

FDA Publishes 2 Revised VICH Guidances

[ Price : $8.95]

FDA publishes two revised Veterinary International Conference on Harmonization guidances on validation of analytical procedures fo...

FDA Clears Thinks Robitic System for 2 Knee Implants

[ Price : $8.95]

FDA clears a Think Surgical 510(k) for the TMini Miniature Robotic System and its use with the GMK Sphere and SpheriKA Knee System...

Merck Discontinues 2 Keytruda Phase 3 Trials

[ Price : $8.95]

Merck says that on the recommendation of independent data monitoring committees, it is discontinuing a Keytruda lung cancer trial ...