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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 ...

Join 2 former FDA inspectors as they explain the consequences of non-compliance and why understanding risk-based approaches is essential for all.

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The US Food and Drug Administration (FDA) has issued a draft guidance to industry that specifies where sponsors should submit @cross-center@ master files (MFs) that are referenced and intended to ...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 ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.