FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

New Fresenius Hemodialysis Device Cleared

[ Price : $8.95]

FDA clears a Fresenius Medical Care 510(k) for its 5008X Hemodialysis High-Volume System.

Rule on Master Files and Biologics

[ Price : $8.95]

FDA issues a final rule to amend its regulations about the use of master files for biological products.

FDA/Philips Dispute on CPAP Safety Revealed: Report

[ Price : $8.95]

A new ProPublica/Pittsburgh Post-Gazette article reveals that in the early days of the 2021 recalls by Philips Respironics of its ...

FDA Debars Brendon Gagne for 5 Years

[ Price : $8.95]

Federal Register notice: FDA issues an order debarring Brendon Gagne for five years from importing or offering for import any drug...

Qmiiz Not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that TerSera Therapeutics Qmiiz (meloxicam) orally disintegrating tablets, 7.5 mg and 15 m...

Panel to Select Flu Vaccine Strain Target

[ Price : $8.95]

Federal Register notice: FDA announces a 3/5 meeting of the advisory committee that will discuss strains to be included in next se...

Wake Up and Do Something: Califf on Misinformation

[ Price : $8.95]

FDA commissioner Robert Califf tells a George Washington University presentation on healthcare misinformation and disinformation t...

Chinese API Maker Hit with FDA-483

[ Price : $8.95]

FDA posts a six-item Form FDA-483 from a 9/2023 inspection at Sichuan Deebio Pharmaceutical Co. in Guanghan, Sichuan, China.

De Novo Pathway Challenges and Opportunities

[ Price : $8.95]

Three academic researchers say the FDA de novo medical device pathway has the potential to attract innovators who want to define n...

CDER Tests Communications for Clarity

[ Price : $8.95]

CDER Office of Communications social scientist Alexandria Smith says the Center tests some communications intended for consumers o...