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Human Drugs

HHS Touts Pharmacy on Demand Project

HHS touts its work with On Demand Pharmaceuticals Pharmacy on Demand modular drug manufacturing unit that uses artificial intelligence and machine lea...

Medical Devices

FDA Clears DeepSights NeedleVue Ultrasound

FDA clears a DeepSight Technology 510(k) for its NeedleVue LC1 Ultrasound System for image-guided medical procedures.

Human Drugs

OPQ MAPP to Speed Some NDA, BLA Approvals

FDA issues a Manual of Policies and Procedures for CDER Office of Pharmaceutical Quality regulatory flexibility to help overcome chemistry, manufactur...

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FDA General

FDAer Quits, Flips Off Trump/Vance in Viral Post

FDA Office of Privacy information specialist Elizabeth Booker Houstons recent departure goes viral after dramatically announcing her resignation with ...

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FDA General

Agency RIF Packets Cause Privacy Concerns

Some fired FDA employees say they received sensitive information about other employees in addition to their own.

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Human Drugs

CGMP Issues at Private Label Grooming

FDA warns Henderson, NV-based Private Label Grooming about CGMP violations in its production of over-the-counter drugs.

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Medical Devices

Multiple Violations in Spectra Therapy Inspection

FDA warns Port Huron, MI-based Spectra Therapy about Quality System, Medical Device Reporting, and Unique Identifier violations in its production of a...

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Human Drugs

Promising Ianalumab Data for Thrombocytopenia: Novartis

Novartis says its experimental antibody ianalumab, when combined with eltrombopag, significantly extended the time to treatment failure in patients wi...

Medical Devices

Draeger Recalls Ventilator Breathing Filters

Draeger recalls (Class 1) its SafeStar and TwinStar breathing filters due to a risk of misleading carbon dioxide readings.

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Elsa Hallucinations Not A Surprise: AI Expert

AI expert Brooke Moy says FDA may have felt pressured to move too quickly to implement its Elsa internal AI tool without planning for sufficient human...