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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...

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.

FDA Dims LASIK Harms it Found in Life Quality Study

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In a long-awaited report on the post-surgical quality of LASIK patients, FDA downplays the harms it found in up to 45% of 572 pati...

Comments Sought on Blood CGMPs

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Federal Register Notice: FDA seeks comments on a proposed collection of information on CGMP requirements for blood and blood compo...

Soto Debarred

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Federal Register Notice: FDA issues an order debarring Kelvin Soto for a period of six years from any contact to a person with an ...

Guidance on Veterinary CMC Data Submissions

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Federal Register Notice: FDA releases a draft guidance: Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections...