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Human Drugs

Right-to-Try Legislation Would Hurt Patients: Ethicist

Medical ethicist Arthur Caplan outlines steps Congress could take to improve access of terminally ill patients to experimental drugs outside clinical ...

Human Drugs

Nephron Pharmaceuticals FDA-483

FDA publishes an FDA-483 containing four observations from an April inspection at Nephron Pharmaceuticals.

Medical Devices

ReFlow Recalls Wingman35 Catheters

FDA says ReFlow Medical is recalling Wingman35 crossing catheters distributed between 1/205 and 3/2016.

FDA General

HELP Committee Schedules 5/10 Mark-up of User Fees Bill

Senate Health, Education & Pensions Committee leaders schedule a 5/10 mark-up of S 934 Food and Drug Administration Reauthorization Act, a bill to rea...

Medical Devices

Newport Medical Class 1 Recall of HT70 Ventilators

FDA classifies as Class 1 a recall of Newport Medical Instruments Newport HT70 and Newport HT70 Plus ventilators due to a software issue that may caus...

Biologics

HCT/P Donor Eligibility Test Guidance

FDA issues a final guidance on testing living donors of human cells, tissues, and cellular and tissue-based products for West Nile Virus.

Human Drugs

AMC Policies Modestly Reduce Detailed Drug Prescriptions

Research published in the Journal of the American Medical Association shows modest but significant reductions in prescribing of detailed drugs at some...

Medical Devices

FDA Clears Luminex ARIES Bordetella Assay

FDA clears a Luminex Corp. 510(k) for the ARIES Bordetella Assay for detecting and identifying of Bordetella pertussis and Bordetella parapertussis nu...

Human Drugs

Gottlieb Facing 3 Complex Challenges: Blog Post

A Health Affairs blog post suggests ways in which FDA commissioner nominee Scott Gottlieb could address three complex challenges facing the agency.

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Criticare Technologies, Organ Recovery Systems, Sal Pharma and Unetixs Vascular.