The European Medicines Agency (EMA) has published a guidance on how companies submitting marketing authorization applications ...

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

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

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

The Indian government has simplified the regulatory framework for outsourced sterilization of medical devices as part of a push to support businesses. Under its “ease of doing business” drive, the ...

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

Industry stakeholders want the US Food and Drug Administration (FDA) to expand the scope of its recent draft guidance on the ...

Pharmaceutical industry groups argue that the US Food and Drug Administration (FDA) should provide clearer guidance on the ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.