FDA issues a final rule to amend its regulations about the use of master files for biological products.
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 notice: FDA issues an order debarring Brendon Gagne for five years from importing or offering for import any drug into the U.S.
Federal Register notice: FDA determines that TerSera Therapeutics Qmiiz (meloxicam) orally disintegrating tablets, 7.5 mg and 15 mg, were not withdraw...
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.
FDA commissioner Robert Califf tells a George Washington University presentation on healthcare misinformation and disinformation that the country need...
FDA posts a six-item Form FDA-483 from a 9/2023 inspection at Sichuan Deebio Pharmaceutical Co. in Guanghan, Sichuan, China.
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...
