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The US Food and Drug Administration (FDA) is seeking feedback on a competency-based approach to regulating medical devices that utilize generative artificial intelligence (GenAI).

The US Food and Drug Administration (FDA) on Monday finalized guidance on its approach to making therapeutic equivalence (TE) evaluations and assigning therapeutic equivalence (TE) codes for abbreviated new drug applications (ANDAs). These codes are listed in the agency’s Orange Book and denote a drug’s bioequivalence to a reference-listed drug (RLD).

Australia’s Therapeutic Goods Administration (TGA) has started a consultation into proposed changes to support automated decision making (ADM) for listed medicine variation applications.

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: Marina Daineko, senior manager, compliance assurance at EPAM Systems. 

Documentation failures create an evidence problem, but their larger effect is risk and uncertainty.

The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to the development of cellular and gene therapy (CGT) products.

Using the US Food and Drug Administration’s (FDA) plausible mechanism framework to allow for greater use of causal inference may help with evidence generation for rare diseases, according to a recent paper published in The Journal of Clinical Investigation.

The European Medicines Agency (EMA) is holding a consultation about a draft framework intended to cut the time it takes to implement data standards.

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