The European Medicines Agency (EMA) has published a guidance on how companies submitting marketing authorization applications ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and ...
Industry stakeholders want the US Food and Drug Administration (FDA) to expand the scope of its recent draft guidance on the ...
The UK government has filed legal amendments intended to modernize the regulation of medicines and medical devices.
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
The European Medicines Agency (EMA) has launched a voluntary data submission (VDS) pilot to allow drug developers to share data generated by new approach methodologies (NAM), which regulators say may ...
Sponsors who want to use digitally derived endpoints from digital health technologies (DHT) should validate those endpoints ...
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