Software FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness appsBy Loknath DasSeptember 27, 20190 This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a…
Finance Sarepta inventory nuked by FDA outlookBy DeepMay 12, 20160 res of Sarepta Therapeutics nearly halved on Thursday after the meals and Drug management maintained its “poor” outlook on the…