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PhRMA, Genetic Alliance Working on Patient-focused Drugs

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PhRMA announces a joint program with the Genetic Alliance to use crowd-sourced technology to learn patients experiences with three...

RTI to Research Drug Ads for FDA

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FDA awards a $4 million contract to RTI International for five studies of various aspects of consumer response to DTC drug ads.

Moban Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Moban tablets and capsules were not withdrawn from sale for reasons of safety or effe...

Guidance on Developing Tuberculosis Drugs

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Federal Register Notice: FDA releases a guidance, Pulmonary Tuberculosis: Developing Drugs For Treatment.

Public Meeting on Sickle-Cell Disease

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Federal Register Notice: FDA plans a public meeting 2/7/14 on patient-focused drug development for sickle cell disease.

Opportunity for Hearing on Withdrawal of 14 NDAs

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Federal Register Notice: FDA announces an opportunity to request a hearing on a proposal to withdraw approval of 14 NDAs.

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...