RAPS

FDA updates guidance on expanded access for investigational drugs under IND

The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now ...
RAPS

FDA updates patient preference guidance to span the product life cycle

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance that would significantly revise its previous guidance on using voluntary patient preference information (PPI) for medical ...
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FDA advances OTC monograph updates alongside broader access push

The FDA is moving forward with updates to over-the-counter (OTC) drug monographs and labeling requirements, aiming to modernize rules and improve consumer access. Commissioner Marty Makary has ...

US FDA to monitor clinical trial data in real time in pilot program aimed at speeding approvals

By Ahmed Aboulenein WASHINGTON, April 28 (Reuters) - The U.S. Food and Drug Administration launched a pilot program on Monday aimed at allowing the agency to monitor clinical trial data in real time, ...