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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 ...

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...

Celltrions Humira Biosimilar Now Interchangeable: FDA

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FDA grants interchangeable biosimilar status to Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.

Trump to FDA: Boost Generics, OTCs, Rx Imports

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A presidential executive order tells FDA to suggest administrative and legislative ways to improve the availability of generic and...