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Guide on IVD Biotin Interference Testing

[ Price : $8.95]

FDA posts a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices.

Former FDA Spokeswoman Lands as Chief of Staff Advisor

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Despite being removed from her post, controversial former FDA chief spokeswoman Emily Miller remains at the agency as senior advis...

Device Advisory Panels Seek Voting Members

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Federal Register notice: FDA seeks nominations for voting members to serve on its Device Good Manufacturing Practice Advisory Comm...

Draft Guide on Biocompatibility of Devices Contacting Skin

[ Price : $8.95]

CDRH posts a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.

Labeling Carve-Out Court Decision Explained

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Attorney Sara Koblitz says a Federal Circuit Court of Appeals decision casts doubt on the long-established practice of generic dru...

Technical Considerations for Devices with Nitinol

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FDA issues a guidance on technical considerations for non-clinical assessment of medical devices containing nitinol.

Technical Suggestions on FDA Myeloid Leukemia Guidance

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Six drug companies submit technical comments on an FDA draft guidance on drug development for acute myeloid leukemia.

Flu Test Modification Enforcement Discretion Policy

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FDA says it will exercise enforcement discretion for some modifications to molecular influenza tests during the Covid-19 pandemic.

Lilly Covid Plant Fails FDA Reinspection

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An FDA reinspection at a troubled Eli Lilly drug manufacturing plant in Branchburg, NJ finds additional GMP problems that could po...

Bayer sNDA Seeks Mirena Use for 7 Years

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Bayer files a supplemental NDA seeking to extend the duration of use for up to seven years for its intrauterine device Mirena (lev...