For Immediate Release: September 12, 2024 Español Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones. Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions
For Immediate Release: September 11, 2024 Today, the U.S. Food and Drug Administration issued warning letters to two Chinese nonclinical testing laboratories, citing both for laboratory oversight failures and animal care violations that raise concerns about the quality and integrity of data generated by the labs. Warning letters were issued to Mid-Link Testing Company Ltd.
For Immediate Release: September 10, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Â Today, the FDA posted a warning letter issued to Root Bioscience Brands LLC, doing business as Naternal, for illegally selling cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN) products for people and
For Immediate Release: September 03, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Â On Sept. 11 from 1-2 p.m. ET, the FDA will host a virtual Medical Device Sterilization Town Hall: Sterility Master Files and Effective Use in Premarket Submissions. Registration is not required
For Immediate Release: August 30, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Â On Thursday, the FDA approved a new indication for ACAM2000, to include the prevention of mpox disease in individuals determined to be at high risk for mpox infection. ACAM2000 has been
