The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...

RAPS and Elemed are pleased to release the 2nd edition of this ground-breaking white paper, which provides a snapshot of the ...

Two former US Food and Drug Administration (FDA) officials have commented on and proposed changes to the agency’s recent draft guidance on the development of a plausible mechanism framework for ...

AI drug developer Insilico Medicine and Lilly ink commercialization deal worth up to $2.75 billion ( STAT) AstraZeneca’s in ...

Following the trend of other regulators, the European Medicines Agency (EMA) is taking steps to reduce the need for animal testing. The agency has issued a draft qualification opinion for a new ...

A reviewer-informed discussion on managing regulatory submissions across their full lifecycle—from assembly through health authority review—focusing on clarity, traceability, and change management.

Regulatory Focus is the only source of timely, quality news and information fully dedicated to daily online coverage of the global regulation of healthcare products. An experienced team of reporters ...

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, ...

Recon: Novo to offer discount Wegovy subscription for self-pay US consumers; Lilly to acquire Centessa in deal worth up to $7.8B Join one of the many groups where you can pursue your regulatory ...

Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good ...

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...

Stakeholders are being encouraged to weigh in on the European Chemicals Agency (ECHA) 60-day public consultation period related to a planned ban on per-and-polyfluoroalkyl (PFAS) substances, also ...