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FDA General

FDA Webview Experiencing Technical Difficulties

FDA Webview experiences technical difficulties that could limit the amount of text displayed in our current stories.

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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.

Biologics

Celltrions Humira Biosimilar Now Interchangeable: FDA

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

Human Drugs

Trump to FDA: Boost Generics, OTCs, Rx Imports

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

Human Drugs

Petition Seeks GMP Amendment for Sampling Logbooks

A citizen petition urges FDA to amend the requirements under 21 CFR Part 211 (finished pharmaceuticals GMPs) to mandate the use of separate sampling l...

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...