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AdvaMed Comments on Inspection Delay Guidance

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AdvaMed suggests changes to an FDA draft guidance on delaying, denying, limiting, or refusing a drug or device inspection.

Panel Unanimously Backs Non-Rx Narcan

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A joint FDA advisory committee meeting votes to recommend the nonprescription use of Emergent BioSolutions Narcan (naloxone HCl) n...

Device UDI Information Collection Revision

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Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device Labeling Requirements; Unique...

Guide on Neonatal Neurodevelopmental Safety

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Federal Register notice: FDA makes available a draft guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Sa...

Soligenix Gets Refuse-to File Letter on HyBryte

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FDA issues Soligenix a refuse-to-file letter for its HyBryte (synthetic hypericin) NDA that is seeking an indication for treating ...

CGMP Violations in Delta Kozmetik Sanayi Inspection

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FDA warns Tuzia/Istanbul, Turkey-based Delta Kozmetik about CGMP violations in its production of finished drugs.

Multiple Violations in Unapproved Wintech Medipro Masks

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FDA warns Katy, TX-based Wintech Medipro about multiple violations in its manufacturing and distribution of unapproved surgical ma...

11 Republicans See FDA/Industry Revolving Door

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Eleven Republican members of Congress ask FDA and other agencies to respond to disputed claims that FDA drug reviewers take it eas...

FDA Staff Take Aim on ICH Model-Informed Development

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FDA says staff from CDER and CBER are participating on a new International Council on Harmonization formal expert working group to...

FDA Alternative Review Tools Critical in Decisions: Study

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FDA researchers say the alternative tools employed in CDER inspections during the pandemic were critical to informing agency regul...