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Human Drugs

FDA Inspections Will Suffer Under FDA Cuts: Lawyers

Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approval...

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Medical Devices

Bard Recalls BD 4 Fr. PowerPICC Catheters

Bard Access Systems recalls its BD 4 Fr. Single Lumen PowerPICC Catheters due to tubing that exceeded melt flow index specifications, which could lead...

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Medical Devices

QApel Recalls Aspitration System

QApel Medical recalls and discontinues the marketing of its 072 Aspiration System (also known under the product name Hippo and Cheetah) based on conce...

Human Drugs

Rare Disease Drug Development Articles

Researchers publish two journal articles relating to rare disease drug development.

Human Drugs

AI in Regulatory Science: Conference Report

A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligence to meet new demand...

Medical Devices

Digital Health Technologies an FDA Priority: Article

Three FDA staffers discuss the agencys efforts to advance the use of digital health technologies in clinical trials.

Animal Drugs

Inspections Will Suffer Under FDA Cuts: Lawyers

Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approval...

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EIRS/483s

Hill Staffer Graham Appointed to FDA Policy Office

FDA appoints Capitol Hill staffer Grace Graham as deputy commissioner for policy, legislation, and international affairs.

FDA General

FDA Wants Contractors to Replace Some Fired Staff

FDA is recruiting contractors to do the travel logistics work for inspections and investigations that was done by staff who have been fired, according...

Medical Devices

2 Medical Device FAQs Issued

FDA issues two documents answering frequently asked questions about reporting medical device recalls, corrections, and adverse events.