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Rare Disease Drug Development Articles

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

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 ...

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...

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...

2 Medical Device FAQs Issued

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