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Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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.
US Food and Drug Administration (FDA) officials are still @working out the details@ of the plausible mechanism pathway being proposed by FDA Commissioner Marty Makary, said Teresa Buracchio, director ...
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.
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 ...
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 ...
The US Food and Drug Administration (FDA) on Monday published an untitled letter it sent to AstraZeneca on 23 September concerning a TV commercial for its drug Farxiga (dapagliflozin).@ Regulators ...
The European Medicines Agency (EMA) has set out actions to improve scientific advice and accelerate regulatory processes in public health emergencies.
The European Artificial Intelligence (AI) Act is one of the most challenging new regulations facing manufacturers. The act introduces new concepts, like human oversight and data management, that ...
The US Food and Drug Administration (FDA) has issued a draft guidance to industry that specifies where sponsors should submit @cross-center@ master files (MFs) that are referenced and intended to ...
For today’s regulatory professionals, continuous audit readiness is essential. With evolving standards like ICH E6 (R3) and increased global scrutiny, being inspection-ready every day ensures ...
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