FDA Related News

Human Drugs

Orphan Status for Polycythemia Vera Drug

FDA grants Disc Medicine an orphan drug designation for DISC-3405 for treating patients with polycythemia vera.

Medical Devices

Samsung Wins De Novo for Sleep Apnea Watch, Phone

FDA grants Samsung Electronics a de novo authorization for a sleep apnea feature using a compatible Samsung Galaxy Watch and phone.

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Qmiiz Not Withdrawn Due to Safety/Efficacy: FDA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.