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Panelists Review CDRH Digital Health Goals

[ Price : $8.95]

CDRH holds a second listening session on its new Digital Health Center of Excellence and examines whether it is pursuing the most ...

Expiration Date Extended for 42 Cutaquig Lots

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FDA extends from 24 to 36 months the expiration date for 42 lots of Cutaquig if they are stored at a cooler temperature.

Neuronetics TouchStar Protocol Cleared for Depression

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FDA clears a Neuronetics 510(k) for its TouchStar treatment, a three-minute intermittent theta burst protocol for use with its Neu...

FDA Recognizes ANSI Accreditation Board for ASCA Pilot

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FDA recognizes the ANSI board as an accreditation body for the agencys Accreditation Scheme for Conformity Assessment pilot projec...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company AuroLife Pharma.

5 FDA Areas of Likely Emphasis in Biden Administration

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Three Covington & Burling attorneys identify five areas of FDA work where the Biden administration may exercise priorities.

FDA Support for U.S.-Mexico-Canada Trade Agreement

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FDA senior trade advisors outline reasons why the new U.S.-Mexico-Canada agreement is better for the agency and public health than...

Guide on Contraceptive Drug Interaction Studies

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Federal Register notice: FDA makes available a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contra...

Animal Drug Impurities Q&A Guidance

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Federal Register notice: FDA makes available a final guidance on elemental impurities in animal drug products.

HHS Moves to Terminate FDA Unapproved Drugs Initiative

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HHS moves to terminate FDAs unapproved drug initiative as part of Trump administration efforts to reduce prescription drug costs.