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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.

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...

Digital Health Technologies an FDA Priority: Article

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

Makary Says FDA Exploring Conditional Approvals

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FDA commissioner Marty Makary says the agency is exploring the use of a new drug approval pathway for rare diseases and incurable ...

Leaked Budget Document Projects FDA Cuts: Report

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An FDA Matters blog post analyzes a leaked document purporting to show a 17% decrease in FDA budget authority spending for FY 2026...

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 ...