Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...

The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, ...

The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid ...

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

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

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 ...

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.

Two former US Food and Drug Administration (FDA) officials have commented on and proposed changes to the agency’s recent ...

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 ...

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 ...

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 ...

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, ...