Regulatory professionals must navigate change and uncertainty amid an evolving global regulatory landscape, new technologies such as artificial intelligence (AI), and the rapid pace of scientific ...

Clinical performance data for medical devices with artificial intelligence (AI) features is often unavailable, making it difficult to assess real-world outcomes and potentially jeopardizing safety, ...

This article reviews the changes in China@s national food safety control system and update on national food safety standard system and describes the country@s unique regulations and requirements for ...

Nutrition and health claims are widely used on food labels and may positively influence consumer perceptions and intentions to buy food. Regulation (EC) 1924/2006 on nutrition and health claims aims ...

COVID-19 vaccine initiatives OWS: Operation Warp Speed is a collaboration of several US government departments including Health and Human Services (HHS) and subagencies, Defense, Agriculture, Energy ...

The US Food and Drug Administration (FDA) has published scores of warning letters, most of them to companies for marketing and advertising compounded versions of glucagon-like Peptide-1 (GLP-1) ...

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 Trump Administration is seeking $6.8 billion to fund the US Food and Drug Administration (FDA) in FY 2026 @ an 11.5 percent cut from its current budget authority @ with the agency looking to ...

The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter monograph ...

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 ...

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 ...