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RAPS is proud to serve as the largest and most trusted global organization dedicated to supporting and advancing the regulatory profession and enhancing the development and careers of regulatory and quality professionals worldwide.
News
FDA finalizes Q&A guidance on developing cell and gene therapies
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.
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Experts discusses need to modernize evidentiary models in rare diseases
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 Investigatio
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Euro Roundup: EMA seeks feedback on framework designed to drive uptake of data standards
The European Medicines Agency (EMA) is holding a consultation about a draft framework intended to cut the time it takes to implement data standards.
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Recon: FDA approves Ultragenyx gene therapy for glycogen storage disorder; Overton faces confirmation challenges
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devices
More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices suggests the need for greater postmarket surveillance, accordi
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