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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 ...
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 ...
Stakeholders are asking the US Food and Drug Administration (FDA) to treat disseminated coccidioidomycosis as a rare disease for trial design and regulatory purposes.
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The US Food and Drug Administration (FDA) has issued a draft guidance to industry that specifies where sponsors should submit @cross-center@ master files (MFs) that are referenced and intended to ...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 ...
The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing ...
Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, more ...
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.
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