Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
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, ...
Several patient and disease advocacy organizations have responded to the Center for Drug Evaluation and Research's (CDER) ...
The US Food and Drug Administration (FDA) has announced that starting on 1 October 2026, manufacturers must submit adverse ...
Hong Kong’s Department of Health (DH) has begun a phased transition to the independent assessment of primary data on 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, ...
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 ...
The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA IV) program, ...
AI drug developer Insilico Medicine and Lilly ink commercialization deal worth up to $2.75 billion ( STAT) AstraZeneca’s in ...
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, ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
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