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The US Food and Drug Administration (FDA) is requesting feedback on possible solutions that would help sponsors more effectively submit patient-level real-world data (RWD) and real-world evidence (RWE) for drug and biological product applications.

BARCELONA – Experts said that specialized artificial intelligence (AI) tools can be invaluable in helping companies address regulatory needs for medical devices, while saving time and money, during a panel discussion at the RAPS AI in Regulatory Conference. However, they noted significant limitations of such tools, which ultimately rely on subject matter experts being in control of the AI.

The European Medicines Agency (EMA) is seeking feedback on the information needed for the approval of biomarker-guided medicinal products.

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The US Food and Drug Administration (FDA) has issued draft guidance to assist sponsors in developing early-phase first-in-human (FIH) studies for investigational drugs and biologics aimed at treating solid tumors as part of Operation TrialBlazer.

BARCELONA – Experts noted that companies shouldn’t wait until a law is enacted to begin developing regulatory intelligence. Instead, they recommended that regulatory professionals engage with key stakeholders early to ensure they are prepared to implement the regulations and have a say in their implementation.

Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas said there is significant public interest in its recently announced Expedited Investigational New Drug (IND) pilot at the Friends of Cancer Research (FOCR) annual meeting on Tuesday.

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

BARCELONA – A panel of experts said that while technologies such as artificial intelligence (AI) can help aggregate and process vast amounts of regulatory information, regulatory professionals and human relationships are still needed to translate intelligence signals.

The US Food and Drug Administration (FDA) on Monday finalized guidance to assist manufacturers in validating in vitro diagnostic devices (IVDs) that test for emerging pathogens during public health emergencies. The guidance also provides recommendations on how this validation data should be submitted in a pre-Emergency Use Authorization (EUA) or an EUA request.