FDA posts a final guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex (MAC): Developing Drugs for T...
FDA posts a draft guidance entitled Post-Warning Letter Meetings Under GDUFA that provides information on implementing the new program that was create...
Federal Register notice: FDA makes available a guidance to describe that enforcement policies will be extended for an additional year for certain whol...
FDA clears a 23andMe 510(k) to expand its existing BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report by allowing it to report an additional 4...
FDA says Universal Meditech has recalled all test products manufactured between 3/2021 and 11/2022 because the company is ceasing operations.
Korea-based Hugel resubmits its BLA for its botulinum toxin Letybo (letibotulinumtoxinA), indicated for treating glabellar (frown) lines.
Sage Therapeutics says it is downsizing and reorganizing to prepare for the launch of its postpartum depression drug Zurzuave later this year.
Becton Dickinson asks the FDA Microbiology Devices Panel to consider four points at its 9/8 discussion of diagnostic devices in future pandemics.
