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Urgent Steps to Counter Need for Chinese Drugs: Exiger

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Two reports highlight U.S. dependence on foreign sources for APIs and finished drugs and call for urgent steps to reduce that depe...

FDA Restricting Industry Reps on Advisory Committees

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FDA commissioner Marty Makary announces a new policy directive that limits those employed at regulated industries from serving as ...

Panel on Opioid Overdose Studies

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Federal Register notice: FDA reschedules a previously planned drug safety advisory committee involving opioid overdose risk studie...

AI in Regulatory Science: Conference Report

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A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligenc...

FDA Inspections Will Suffer Under FDA Cuts: Lawyers

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

Bard Recalls BD 4 Fr. PowerPICC Catheters

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Bard Access Systems recalls its BD 4 Fr. Single Lumen PowerPICC Catheters due to tubing that exceeded melt flow index specificatio...

QApel Recalls Aspitration System

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QApel Medical recalls and discontinues the marketing of its 072 Aspiration System (also known under the product name Hippo and Che...

Rare Disease Drug Development Articles

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

Hill Staffer Graham Appointed to FDA Policy Office

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

FDA Wants Contractors to Replace Some Fired Staff

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