In a new draft guidance, the US Food and Drug Administration (FDA) has provided details on the clinical investigation requirements that sponsors of new drugs must meet to obtain three years of ...

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 ...

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 ...

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 @ ...

This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not ...

Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special @priority review@ vouchers which allow its recipient to expedite the review of any one of its new drug products.

BRUSSELS @ Experts from the European Commission shed light on the proposed wide-ranging changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) that have been put ...

This article discusses key elements of the In Vitro Diagnostic Regulation (IVDR) and the challenges it presents to manufacturers.

The US Food and Drug Administration (FDA) on Thursday issued warning letters to 12 manufacturers and retailers for illegally marketing breast binders to children for gender-affirming surgery. The ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, the ...

After canceling a routine meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review the composition of the 2025-2026 influenza vaccine, the US Food and 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 ...