FDA Related News

Human Drugs

New Fresenius Hemodialysis Device Cleared

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

Human Drugs

Rule on Master Files and Biologics

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

Human Drugs

FDA/Philips Dispute on CPAP Safety Revealed: Report

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

Federal Register

FDA Debars Brendon Gagne for 5 Years

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

Human Drugs

Qmiiz Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that TerSera Therapeutics Qmiiz (meloxicam) orally disintegrating tablets, 7.5 mg and 15 mg, were not withdraw...

Federal Register

Panel to Select Flu Vaccine Strain Target

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

Wake Up and Do Something: Califf on Misinformation

FDA commissioner Robert Califf tells a George Washington University presentation on healthcare misinformation and disinformation that the country need...

Human Drugs

Chinese API Maker Hit with FDA-483

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

Medical Devices

De Novo Pathway Challenges and Opportunities

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

CDER Tests Communications for Clarity

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