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Trump Promises More FDA Virus Actions

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President Trump says he has asked FDA to cut through red tape and reduce regulatory barriers, presumably to advance products assoc...

CDER Denies NDA Complete Response Appeal

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CDER denies an Acer Therapeutics appeal of a 6/2019 complete response letter on an NDA for Edsivo (celiprolol) for treating vascul...

Janssen NDA Filed for MS Drug

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Janssen Pharmaceutical files an NDA for ponesimod for treating adult patients with relapsing multiple sclerosis.

CGMP Violations at Indias Cipla Limited

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FDA warns Indias Cipla Limited about CGMP violations in its production of finished drugs.

FDA Releases Purell Warning Letter

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FDA warns Gojo Industries its Purell Healthcare Advanced Hand Sanitizer product line is considered an unapproved new drug that can...

Liquid Drug Flow Restrictor Guidance

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FDA publishes a draft guidance on using flow restrictors for oral liquid drug products to limit unintentional ingestion by childre...

Windlas Healthcare Inspection Sees CGMP Issues

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FDA warns Indias Windlas Healthcare Private Limited about CGMP violations in its manufacturing of finished drugs.

TransMedics PMA Panel Meeting Postponed

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FDA postpones a 4/16 advisory committee meeting that was to review a TransMedics PMA for the TransMedics Organ Care System.

3 NDAs Withdrawn Over No Annual Reports

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Federal Register notice: FDA withdraws approval of three NDAs from multiple holders because they repeatedly failed to file require...

FDA Gives States Coronavirus Testing Authority

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FDA updates a policy on diagnostic testing for coronavirus that allows states to take responsibility for tests developed and used ...