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Human Drugs

Texas Sues Lilly Over Illegal Kickbacks

Texas attorney general Ken Paxton sues Eli Lilly for violating state law by giving illegal kickbacks to healthcare providers as inducements to prescri...

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Human Drugs

2 Charged for Misbranded Imported Drugs

The Justice Department says two men have been charged and one has agreed to plead guilty in a case involving the importation, repackaging, and distrib...

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Human Drugs

Ocular Therapeutix Gets FDA Trial Protocol Agreement

Ocular Therapeutix receives FDA agreement on a Special Protocol Assessment for evaluating Axpaxli in the treatment of non-proliferative diabetic retin...

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Human Drugs

New Methods for Pediatric Drug Safety Workshop

FDA announces a 12/5 Public Workshop on Pediatric Drug Development Safety and New Approach Methodologies.

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Medical Devices

De Novo OK for ArteraAI Prostate Software

FDA grants de novo authorization for the ArteraAI Prostate test, a risk-stratification tool to help providers and patients make treatment decisions ba...

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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.