The third edition of Regulatory Intelligence 101 was developed for all regulatory professionals who generate regulatory intelligence, particularly those who deliver this key service to others in their ...
The International Council for Harmonisation@s (ICH) Cell and Gene Therapy Discussion Group (CGTDG) recently released a discussion paper recommending a more tailored approach in its guidelines for cell ...
RAPS Euro Convergence unites regulatory affairs professionals and industry partners to share and collaborate on solutions for the improvement and advancement of healthcare in Europe.
More than five years after the US Food and Drug Administration (FDA) asked manufacturers to pull drugs with ranitidine off the shelves due to concerns of elevated cancer risk, the agency has approved ...
The American College of Gastroenterology (ACG) has urged the US Food and Drug Administration (FDA) to consider certain inclusion and exclusion criteria when asking sponsors to conduct clinical trials ...
The US Food and Drug Administration (FDA) has issued a draft guidance to industry that specifies where sponsors should submit @cross-center@ master files (MFs) that are referenced and intended to ...
Industry, patient groups, and academics seek more clarity from the US Food and Drug Administration (FDA) regarding its plans to require drug and biologic manufacturers to update their labeling after ...
Pharmaceutical industry stakeholders suggested some modifications to the US Food and Drug Administration@s (FDA) recently released draft clinical outcome assessments (COA) template for ensuring that ...
Recon: Abbott to acquire Exact Sciences in 21B deal Merck KGaA pairs with Valo for AI drug discovery
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The European Medicines Agency (EMA) has set out actions to improve scientific advice and accelerate regulatory processes in public health emergencies.
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