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The rise and fall of a fake decongestant: What phenylephrine tells us about the history of the FDA

Tiny Matters

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Evolution of Drug Approval and FDA Regulations

This chapter explores the intricate process of drugs becoming FDA-approved, from preclinical work to post-marketing studies, emphasizing safety and efficacy evaluations. It also delves into the historical evolution of the FDA, highlighting the story of Dr. Francis Oldham-Kelsey and the impact on drug regulations. Additionally, it discusses the shift in popularity between nasally-decongesting drugs and challenges faced by the FDA in evaluating historical data for modern standards.

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