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FDA View on Paclitaxel-Coated Devices Updated

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Three FDA staffers give an update on the agencys position on paclitaxel-coated devices used to treat peripheral arterial disease.

Pandemic Monoclonal Antibody Potency Assay Guidance

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FDA issues an immediately effective guidance to help sponsors develop monoclonal antibodies and other therapeutic proteins for tre...

FDA 6-Month PREPP Initiative Report

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FDA issues a report summarizing its Pandemic Recovery and Preparedness Plan Initiative work in the second half of 2020.

Several Topics in Ongoing PDUFA Reauthorization Negotiations

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FDA releases minutes and meeting summaries for five PDUFA 7 negotiation meetings at the end of 2020.

Woodcock Likely Acting Commissioner After Inauguration

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Former CDER director Janet Woodcocks recent move to the Office of Commissioner sets in motion her likely elevation to acting commi...

Rule on Fairness in Enforcement Actions

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Federal Register notice: HHS issues a final rule to promote transparency and fairness in civil enforcement actions.

Timber Pharma Wins Orphan Status for Sitaxsentan

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FDA grants Timber Pharmaceuticals an orphan drug designation for TMB-003, a locally delivered formulation of sitaxsentan, indicate...

FDA OKs Marinus Ganaxolone NDA Filing

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FDA tells Marinus that Marigold study data appear sufficient to justify filing an NDA for oral ganaxolone to treat children and ad...

Leading BioSciences Fast Track for GI Dysfunction

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FDA grants Leading BioSciences a fast track designation for LB1148 for treating postoperative gastrointestinal dysfunction associa...

Slaoui Resigns from Warp Speed at Biden Team Request: Report

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CNBC reports that Operation Warp Speed chief adviser Moncef Slaoui has resigned at the request of the incoming Biden administratio...