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FDA to Consider New Study on Mercury Amalgam Risks

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CDRH agrees to consider data from a new study on mercury amalgam toxicity that is being conducted by a Canadian researcher who has...

Watson Settles with Endo Pharma on Opana Generic

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Watson Labs and Endo Pharmaceuticals reach a settlement on patent litigation for Endos Opana ER under which Watson has agreed to n...

Hamburg Guardedly Optimistic on Resources

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Commissioner Margaret Hamburg says she is guardedly optimistic that FDA will continue to get some of the critical support in key a...

Chinese Firm Pleads Guilty to Illegal Drug Marketing

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A Chinese drug company and its CEO plead guilty to U.S. charges of introducing human growth hormone into this country without FDA ...

Officials Describe Illegal Botox Marketing

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Federal officials detail ways in which Allergan boosted sales by illegally marketing its Botox for off-label uses.

Global Drug Market to Grow 5-7%

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IMS Health sees higher global drug market growth in 2011 than in 2010.

FDA/NIH Back Adaptive Trial Designs Research

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FDA and NIH award a $9 million grant for academia-based research on improving adaptive clinical trial designs.

Group Presses for Sunscreen Regs

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Environmental Working Group asks FDA's Nonprescription Drugs Advisory Committee to urge the agency to issue long-awaited regulatio...

Tris Pharma Gains Generic Tussionex Approval

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FDA approves a Tris Pharma ANDA for a generic copy of UCB's Tussionex.

Integra Spinal Fusion Device Cleared

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FDA clears an Integra LifeSciences 510(k) for its Vu aPOD Prime anterior lumbar interbody fusion device.