Top US Food and Drug Administration (FDA) officials said the agency is open to novel, “innovative approaches” to the clinical ...
The US Food and Drug Administration (FDA) has announced the permanent appointment of four top officials to lead the agency's ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The European Medicines Agency (EMA) has published a guidance on how companies submitting marketing authorization applications (MAA) should provide electronic product information (ePI) for products ...
Industry and patient groups have asked the US Food and Drug Administration (FDA) to make several changes to its revised draft ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and ...
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, ...
RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the ...
Industry stakeholders want the US Food and Drug Administration (FDA) to expand the scope of its recent draft guidance on the ...
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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