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Restrictions Sought on Generic Prepopik

[ Price : $8.95]

Ferring asks FDA to require ANDA sponsors to conduct clinical studies to demonstrate bioequivalence of a generic form of its colon...

Lawyers Debate Pinnacle Hips in Trial

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Attorneys for a women who claims design defects in DePuy Pinnacle hips injured her and for the company debate the implants safety ...

FDA Warns Michigan Compounding Pharmacy

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FDA warns Beacon Hill Medical Pharmacy about CGMP and other violations in its production of compounded drugs.

QS Violations in Western/Scott Fetzer Inspection

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FDAs Cincinnati District Office warns Western Enterprises/Scott Fetzer Company about QS violations in its manufacturing of medical...

FDA Guide on Delaying, Denying Drug Inspections

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FDA releases a final guidance on Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection that def...

Omeros Suspends Trial After Unexpected Result in Rat Study

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Omeros Corp. suspends Huntingtons disease trials involving OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, as it fur...

FDA Biomarker Letter of Support for Kidney Markers

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FDA issues a letter of support for further exploration of two kidney biomarkers identified and evaluated by a Critical Path Instit...

FDA Computer Network Vulnerable: OIG

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A HHS OIG audit finds vulnerabilities in FDAs computer network that could make it vulnerable to hackers.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Bethel Nutritional Consulting, Western Enterprises/Scott Fetzer Co., and YoungYo...

FDA Issues TB Diagnostic Device Special Controls Guideline

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FDA issues a guideline on mitigation measures to support Class 2 classification for nucleic acid-based in vitro diagnostic devices...