FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Priority Review Voucher Fee Rate Set

[ Price : $8.95]

Federal Register notice: FDA announces the fee rate for using a priority review voucher for fiscal year 2023.

Guides on Device Surveillance/Post-approval Studies

[ Price : $8.95]

Federal Register notice: FDA makes available final guidances on postmarket surveillance and post-approval study orders.

scPharmaceuticals Gets Heart Failure Drug Approved

[ Price : $8.95]

FDA approves scPharmaceuticals Furoscix (furosemide injection) for treating congestion due to fluid overload in adults with New Yo...

FDA Clears Zeiss Medicals Bipolar Forceps

[ Price : $8.95]

Zeiss Medical Technology gains 510(k) clearance for MTLawton, disposable bipolar forceps made from a copper-base alloy.

FDA Clears Copan Diagnostics Colibr

[ Price : $8.95]

FDA clears a Copan Diagnostics 510(k) for its Colibr, a semi-automated pre-analytical processor that is part of the companys WASPL...

Miscarriage Management Needed on Mifeprex Label: Petititon

[ Price : $8.95]

The American College of Obstetricians and Gynecologists and 48 other reproductive health organizations petition FDA to ask Danco L...

Glaxos Boostrix OKd for Unborn in Third Trimester

[ Price : $8.95]

FDA approves GlaxoSimthKline Biologicals Boostrix vaccine to immunize, during the third trimester, unborn children against pertuss...

FDA Proposal to Destroy Devices Refused U.S. Entry

[ Price : $8.95]

Federal Register proposed rule: FDA proposes a regulation to implement its new authority to destroy a device valued at $2,500 or l...

Biosimilar User Fee Rates Set for FY 2023

[ Price : $8.95]

Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2023.

FDA Issues Abbott EUA for Monkeypox Test

[ Price : $8.95]

FDA issues Abbott Molecular an emergency use authorization for its Alinity m MPXV and its use in detecting the monkeypox virus.