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Attorney Looks at State Efforts Seeking Drug Company Restitution

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Attorney Anthony Vale reviews the legal principles involved when states bring actions against drug companies alleging false or mis...

FDA Animal Regs Reflect September Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect September approval actions and to reflect a sponsor...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Aptalis Pharma US and Globus Medical.

Hamburg Calls Compounding Bill Just a Step

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FDA commissioner Margaret Hamburg calls a drug compounding bill moving through Congress a step and not as comprehensive as the age...

How FDA Dropped Patient Warning Rule from LASIK Approvals

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FDA explains how a little-noticed change in its conditions of approval for LASIK lasers removed a patient-protection requirement t...

FDA Approves Pfizer Updated Embeda Manufacturing Process

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FDA approves a Pfizer prior-approval supplement for Embeda (morphine sulfate and naltrexone hydrochloride) extended release capsul...

HHS Posts 101-page Corp. Integrity Agreement for J&J

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HHS posts a 101-page corporate integrity agreement related to a Johnson & Johnson settlement involving a $2.2 billion fine to reso...

Quality System Violations Found in Aptalis Inspection

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FDAs New Orleans District Office warns Aptalis Pharma about Quality System Regulation violations in its work as a specification de...

Globus Warned About QS Violations

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FDAs Philadelphia District Office warns Globus Medical about Quality System and Medical Device Reporting violations in its manufac...

Albany Molecular Research Resolves 2010 Warning Letter

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FDA issues Albany Molecular Research an inspection close-out letter lifting a 2010 Warning Letter related to its Burlington, MA as...