John Farley has been appointed director of the Office of Infectious Diseases (OID) in the Center for Drug Evaluation and Research’s Office of New Drugs (OND). He had been acting director of OID since ...

The European Commission on Wednesday published the thrice-delayed draft of the contentious legislation that will reshape the regulation of the pharma sector and set the course of the industry for ...

The dietary supplement industry in the US faces increasing class action risk driven by labeling, testing, and compliance claims. Courts continue to apply the reasonable consumer standard when ...

The Department of Government Efficiency (DOGE) this week claimed it had canceled 30 leases for US Food and Drug Administration (FDA) facilities nationwide, including a facility in St. Louis, MO, which ...

President Donald Trump@s order requiring the removal of 10 regulations, rules, or guidances for each new one issued will put administrative pressure the US Food and Drug Administration (FDA) and other ...

Thousands of workers at the US Food and Drug Administration (FDA) were abruptly fired on 1 April as part of President Donald Trump@s effort to reduce the size of the federal government. Many agency ...

This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions @ EU, UK, US, China, and other regions of the world @ ...

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The US Food and Drug Administration (FDA) has finalized guidance that clarifies how the benefits and risks of a drug or biologic factored into the agency@s decisions on whether to approve a new drug ...

The US Food and Drug Administration (FDA) will only conduct vital and mission critical activities amid a government shutdown that began Wednesday after Congress failed to reach a deal to fund the ...

The US Food and Drug Administration (FDA) finalized a rule allowing Institutional Review Boards (IRBs) to waive or alter elements of informed consent for certain clinical trials that pose minimal risk ...

After almost 15 years as director of the Center for Devices and Radiological Health (CDRH), Jeff Shuren announced he will leave the US Food and Drug Administration (FDA) later this year. Starting next ...