The print version of Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective is out of stock. Stay tuned for a brand new edition arriving April 2026. You can still purchase an e ...

The generic drug industry told the US Food and Drug Administration (FDA) that it opposes waiving annual facility fees for the first three years for companies that establish manufacturing operations ...

The US Food and Drug Administration (FDA) recently cited Johnson @ Johnson subsidiary Janssen and Sobi for airing direct-to-consumer (DTC) television ads that failed to sufficiently disclose the risks ...

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 FDA@s ...

BRUSSELS @ The European Commission@s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) include specific changes to the regulation of medical device ...

The European Medicines Agency (EMA) has released a guideline on assessing the quality of inhaled and nasal medicines, as well as a guideline on demonstrating therapeutic equivalence (TE) of orally ...

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 ...

More than half of medical device companies in the EU have reduced their product portfolios to cope with the complexities of the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation ...

The US Food and Drug Administration (FDA) has finalized two guidances for sponsors and investigators regarding adverse event reporting for drugs, biologics, and medical devices in clinical studies.

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 ...

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 ...

A new RAPS digital experience is coming! Parts of our website will be inaccessible between Saturday, 28 March and Wednesday, 1 April during the migration. These services include: the RAPS Marketplace, ...