The European Medicines Agency (EMA) has launched a voluntary data submission (VDS) pilot to allow drug developers to share ...

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

Industry and patient groups have asked the US Food and Drug Administration (FDA) to make several changes to its revised draft ...

The US Food and Drug Administration (FDA) has published a draft guidance on how to design trials and analyze data from ...

The US Food and Drug Administration (FDA) could take additional steps to more successfully implement disclosures of complete ...

Drug manufacturing process models represent a "growing area" of scientific development and are increasingly being utilized in ...

Recon: FDA approves Protagonist and Takeda’s drug for rare blood cancer; Lilly to buy Merida for up to $2.88B Join one of the ...

Sponsors who want to use digitally derived endpoints from digital health technologies (DHT) should validate those endpoints ...

The Indian government has simplified the regulatory framework for outsourced sterilization of medical devices as part of a ...

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Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Alar Pharmaceuticals, accusing the company of ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and ...