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The US federal government is taking steps to have better pandemic preparedness by enhancing regulations. Recent regulatory developments are addressing the need for the U.S. biomedical research community to strengthen biosecurity measures, especially with synthetic biology and research of potentially dangerous pathogens involving Pathogens with Enhanced Pandemic Potential (PEPP) or when artificial intelligence (AI) is…

CDRH leads the way with the most products approved as this list notes of Breakthrough Device Marketing Authorizations. These guidances are related to the Breakthrough Devices Program: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Final Guidance: Breakthrough Devices Program  Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket…

On August 4, 2023, the U.S. Food and Drug Administration (FDA or Agency) issued a final guidance for immediate implementation entitled Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) (Guidance). NDSRIs are a subcategory of nitrosamine impurities that share structural similarity to the active pharmaceutical ingredient (API) in drug products and typically lack compound-specific…