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Crohns Disease Draft Guidance Released

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FDA posts a draft guidance entitled Crohns Disease: Developing Drugs for Treatment that discusses clinical trial considerations.

Gilead Sciences Gets Priority Voucher for Veklury

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Federal Register notice: FDA issues a priority review voucher to Gilead Sciences under the agencys material threat medical counter...

Clinical Hold Lifted on Finch C-diff Therapy

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FDA lifts a clinical hold on a Finch Therapeutics Group IND for CP101, an orally administered microbiome therapeutic which is in l...

5 Tentative Dates for Covid Vaccine Panel Reviews

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FDA announces the tentative Vaccines and Related Biological Products Advisory Committee schedule that has five separate dates the ...

Guide on Ulcerative Colitis Drugs

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FDA posts a draft guidance entitled Ulcerative Colitis: Developing Drugs for Treatment.

FDA Puts Hold on Praxis Epilepsy Therapy

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FDA sends an email to Praxis Precision Medicines that placed a clinical hold on PRAX-222, an antisense oligonucleotide for treatin...

FDA Warns on Medtronic Heartware Ventricular Assist Device

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FDA warns healthcare providers about the possibility that patients who have Medtronics Heartware Ventricular Assist Device System ...

CDER Compliance Priorities Include Covid, Opioids Focus

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CDERs Office of Compliance (OC) says its priorities for 2022 include supporting FDAs Covid-19 response , reducing harm caused by o...

FDA Updates Digital Health Policy Document

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FDA updates its Digital Health Policies Web page to include new information from the Covid-19 public health emergency.

Cupric Sulfate Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Abraxis Pharmaceuticals cupric sulfate injection was not withdrawn from sale for reas...