The agency issued final guidance on mobile apps, saying it will focus only on a subset that present the greatest risk to patients if they don't work correctly.
The advisory panel endorsed the treatment with an 11-2 vote.
FDA draft guidance for generic Advair hits GSK's stock; US looks into GSK's China conduct; Roche invests in cancer and hep. B research; Biogen inks a Parkinson's partnership; Forest names former B&L chief as CEO
Generic Opana ER got the go-ahead from FDA, exposing the drugmaker to generic competition -- unlike Purdue, whose tamper-proof painkiller won standalone status.