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FDA-Industry Alternative Review Model Advances in PDUFA Meeting

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FDA and industry discuss details to develop an alternative user fee review model that could give the agency more review time when ...

Ads Send People to Doctor: AARP

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An AARP poll finds that most people are aware of drug ads and 10% ask doctors for an advertised drug.

Acton Files Supplement to Aerospan NDA

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Acton Pharmaceuticals submits to FDA a manufacturing supplement to its Aerospan Inhalation Aerosol NDA, approved for treating asth...

PhRMA Urges FDA to Require Unique Names for Biosimilars

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Pharmaceutical Research and Manufacturers of America urges FDA to require biosimilar products to each have their own unique non-pr...

FDA Clears GE Patient Monitor

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FDA clears a GE Healthcare 510(k) for the CareScape Monitor B650, a flexible patient monitoring system.

Better Drug Development Incentives Needed: Study

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Harvard professor Aaron Kesselheim says any new market-exclusivity incentives to promote drug development need to be carefully des...

4 New, 5 Updated Medication Guides

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FDA announces new and updated Medication Guides.

Social Media Info Accuracy Questioned

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Researchers say that 25% of postings to Facebook diabetes sites were promotional.

Conflict-of-Interest Rules Can Harm Research Quality: Scholar

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Manhattan Institute visiting scholar Richard Epstein says strict conflict-of-interest rules can work against the information trans...

Watson and Ortho Pen 'Authorized Generic' Agreement for Concerta

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Watson Pharmaceuticals enters into an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals to market an authorized generi...