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Pazdur Sees Trial Designs Changing

[ Price : $8.95]

CDER Office of Hematology and Oncology Products director Richard Pazdur says clinical trial designs are changing to keep up with m...

High Court May Decide if Truthful Speech Can be Prosecuted

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A Forbes article expresses hope that the Supreme Court will hear former InterMune CEO Scott Harkonens appeal and clarify whether i...

Guidance on Screening HCT/P Donors for Syphilis

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Federal Register Notice: FDA releases a draft guidance: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and C...

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.

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...