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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 under the EU's centrally authorized review process. The agency noted that submitting ePI is voluntary until the general pharmaceutical legislation fully goes into effect.

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

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 inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Lisa Wright, director of regulatory policy at Novo Nordisk.

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 inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Jasmine G. Muse, senior manager, regulatory affairs CMC at UCB Biopharma.

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. Several top FDA officials outlined steps they are taking to bolster clinical trial inspections, especially for foreign trials, the agency is seeking input on botanical drugs, and the Department of Health and Human Services (HHS) has issued a new emergency use authorization declaration for military purposes.

Industry stakeholders want the US Food and Drug Administration (FDA) to expand the scope of its recent draft guidance on the types of scientifically valid prior knowledge sponsors may consider when developing gene therapies that involve genome editing to explicitly apply to other types of cell and gene therapies (CGT).

The UK government has filed legal amendments intended to modernize the regulation of medicines and medical devices.

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

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 help reduce the need for traditional animal studies during drug development. The announcement follows other efforts by global regulators to reduce reliance on animal testing.

Sponsors who want to use digitally derived endpoints from digital health technologies (DHT) should validate those endpoints for the intended patient population, pre-specify their missing-data strategy at every level of their clinical trial, and avoid conflating device clearance with endpoint validation, according to US Food and Drug Administration (FDA) officials who spoke at a recent public meeting.