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FDA Failed to Collect $45 bil. Drug Trial Fines: Students

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Johns Hopkins students who belong to Universities Allied for Essential Medicines say FDAs failure to fine companies that dont subm...

Califf Testifies on Accelerated Approvals

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FDA commissioner Robert Califf tells a Senate appropriations hearing that FDA and CMS are working to make sure clinical trials for...

DBV Tech Gets FDA Input in pre-BLA Meeting

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DBV Technologies receives written responses from FDA after a pre-BLA meeting in February about the regulatory path for investigati...

BelGene Gastric Cancer Drug Trial Hits Primary Endpoint

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BelGene says its tislelizumab with chemotherapy met the primary endpoint of overall survival in patients with some gastric cancers...

CGMP Violations at Zermat International

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FDA warns Tlalnepantla, Mexico-based Zermat International about repeat CGMP violations in its manufacturing of over-the-counter dr...

Fresenius Kabi Recalls Ivenix Infusion Device

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Fresenius Kabi recalls its Ivenix Infusion System due to a leak in the device that allows fluid to enter the administration set lo...

Info Collection on Rapid Response Surveys

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Federal Register notice: FDA seeks comments on an information collection extension entitled Rapid Response Surveys.

2 EUAs for Ebola Tests Withdrawn

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Federal Register notice: FDA revokes the emergency use authorizations issued to BioFire Defense for the FilmArray NGDS BT‐E ...

North American Diagnostics Illegal Covid Tests

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FDA warns Holly Hill, FL-based North American Diagnostics it is illegally manufacturing and distributing adulterated and misbrande...

Radiation Syndrome Drug Development Guidance

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FDA publishes a draft guidance with information and recommendations to assist in developing drugs to prevent or treat acute radiat...