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GE Healthcare Recalls Respiratory Accessories

[ Price : $8.95]

GE Healthcare begins a Class 1 recall of its CareScape Respiratory Modules and Airway Gas Option due to a manufacturing issue whic...

Hahn Stresses Product Safety

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In a Politico interview, new FDA commissioner Stephen Hahn stresses the importance of safety in drug importation and dietary suppl...

Conturais Bulkamid OKd for Stress Urinary Incontinence

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FDA approves a Conturais PMA for Bulkamid for treating certain patients with stress urinary incontinence.

Merck Insomnia Drug Gets OK for Alzheimers Patients

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FDA approves an expanded label for Mercks insomnia drug Belsomra (suvorexant) C-IV to include findings on its use for treating ins...

CDRH ASCA 2019 Annual Report

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CDRH issues its FY 2019 annual report for the Accreditation Scheme for Conformity Assessment program.

Changes Expected in User Fee Reauthorizations

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ML Strategies senior director Aaron Josephson predicts discussion topics likely to be included in upcoming negotiations to reautho...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Evig LLC and Won Industry Co.

FDA Allows Emergency Use of Coronavirus Test

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FDA issues a coronavirus emergency use authorization to permit the wider use of a Centers for Disease Control and Prevention 2019-...

Info Collection on Drug Making Emergency Plan

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Federal Register notice: FDA submits to OMB an information collection extension for Planning for the Effects of High Absenteeism T...

Info Collection on FDA Fellowships Apps

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Federal Register notice: FDA sends to OMB an information collection revision entitled Application for Participation in FDA Fellows...