FDA Draft Guidance
A draft guidance publication date determines whether drugmakers get three or five years of market exclusivity.
The regulator is issuing draft guidance to address gene therapies.
The FDA has issued draft guidance that funds FDA inspection of some drug compounders.
Draft guidance indicates the regulator is open to using patient experience as criteria for chronic fatigue syndrome treatments.
The FDA's proposed upgrade to its off-label distribution guidelines has some new features, but experts say it is unclear if this means more dollars will flow toward reprints.
The draft guidance is mostly procedural, and more guidance is expected, but experts say it does include some long-awaited clarity for advertisers.
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FDA draft guidance for generic Advair hits GSK's stock; US looks into GSK's China conduct; Roche invests in cancer and hep.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.
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