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Alliance for Regenerative Medicine AMT Concerns

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The Alliance for Regenerative Medicine raises concerns about an FDA draft guidance on alternative manufacturing technologies.

Opdivo Approved in First-Line Bladder Cancer

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FDA approves Bristol Myers Squibbs Opdivo (nivolumab) for combination use with cisplatin and gemcitabine for first-line treatment ...

6 Reps Want FDA Voucher for Valley Fever

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Five House Republicans and one Democrat from Arizona and California call on FDA to add Valley Fever to the list of tropical diseas...

Medtronic Class 1 Recall of Duet Drainage Device

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FDA classifies as Class 1 a Medtronic Neurology recall of its Duet External Drainage and Monitoring System due to the potential fo...

2 ICH Analytical Procedure Guides Available

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Federal Register notice: FDA makes available two International Council for Harmonization final guidances entitled Q2(R2) Validatio...

Gastrointestinal Drugs Committee Renewal

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Federal Register notice: FDA renews its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter e...

Ventec Life Recalls VOCSN Breathing Package

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Ventec Life Systems recalls its VOCSN Patient Breathing Package due to a manufacturing issue that causes the bonded spiral wrap to...

ICH Analytical Procedure Development Guidance

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FDA publishes the ICH Q14 guidance on analytical procedure development.

Use Healthcare AI for Patients First: Califf

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FDA commissioner Robert Califf expresses fears that healthcare artificial intelligence will be used by health systems to make fina...

ICH Analytical Procedure Validation Guidance

[ Price : $8.95]

FDA publishes the ICH Q2(R2) guidance on validating analytical procedures.