FDA Draft Guidance

New exclusivity rules confound

A draft guidance publication date determines whether drugmakers get three or five years of market exclusivity.

FDA Guidance expands environmental perspective

The regulator is issuing draft guidance to address gene therapies.

Compounders get version of PDUFA

The FDA has issued draft guidance that funds FDA inspection of some drug compounders.

FDA drafts patient-centric CFS guidance

Draft guidance indicates the regulator is open to using patient experience as criteria for chronic fatigue syndrome treatments.

Off-label guidance may not be publishing boon

Off-label guidance may not be publishing boon

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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.

FDA eases rules on ads in social media

FDA eases rules on ads in social media

The draft guidance is mostly procedural, and more guidance is expected, but experts say it does include some long-awaited clarity for advertisers.

FDA exempts most mobile apps from scrutiny

FDA exempts most mobile apps from scrutiny

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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.

Advisory panel backs GSK drug for COPD

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The advisory panel endorsed the treatment with an 11-2 vote.

Business briefs: GSK, Roche, Biogen Idec, Forest

FDA draft guidance for generic Advair hits GSK's stock; US looks into GSK's China conduct; Roche invests in cancer and hep.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

FDA move gives Purdue edge in painkiller market

FDA move gives Purdue edge in painkiller market

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Generic Opana ER got the go-ahead from FDA, exposing the drugmaker to generic competition -- unlike Purdue, whose tamper-proof painkiller won standalone status.


Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.

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