FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Abbott PMA Approved for Amplatzer Amulet

[ Price : $8.95]

FDA approves an Abbott PMA for the Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation who ar...

Comments Extended for Drug Scheduling Notice

[ Price : $8.95]

Federal Register notice: FDA is reopening the comment period for a 7/23 notice on international drug scheduling convention for fiv...

AstraZeneca Can Export Vaccine Made at Emergent Bio: FDA

[ Price : $8.95]

CBER says AstraZeneca can export three lots of Covid-19 vaccine drug substance manufactured at Emergent BioSolutions troubled cont...

Pfizer/BioNTech Booster Data Submitted to FDA

[ Price : $8.95]

Pfizer and BioNTech submit Phase 1 data to FDA to support the evaluation of a booster dose of their Covid-19 vaccine.

CDERs Ellis Unger Retiring After 24 Years at Agency

[ Price : $8.95]

CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger retires to spend more time with family.

Drug User Fee Rates for FY 2022

[ Price : $8.95]

Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2022.

Pfizer, Moderna Booster Authorized for Immunocompromised

[ Price : $8.95]

FDA amends the emergency use authorizations for both Pfizer-BioNTechs and Modernas Covid-19 vaccines to allow for the use of an ad...

Ipsen Withdraws NDA Palovarotene for More Analyses

[ Price : $8.95]

Ipsen withdraws its NDA palovarotene, indicated for preventing heterotropic ossification as a potential treatment for people livin...

SyntrFuge System Cleared for Adipose Tissue

[ Price : $8.95]

FDA clears a Syntr Health Technologies 510(k) for the SyntrFuge System and its use in surgical specialties when the transfer of ha...

FDA Sends Sesen Bio a Complete Response Letter

[ Price : $8.95]

FDA issues Sesen Bio a complete response letter on its BLA for Vicineum (oportuzumab monatox-qqrs) for treating BCG-unresponsive n...