Complex Systems with Patrick McKenzie (patio11) cover image

From molecule to medicine, with Ross Rheingans-Yoo

Complex Systems with Patrick McKenzie (patio11)

CHAPTER

Navigating Accelerated Drug Approval

This chapter explores the concept of accelerated approval in the pharmaceutical industry, allowing quicker market entry of drugs based on preliminary safety and efficacy data. It delves into the historical context, highlighting key regulatory changes spurred by past tragedies like thalidomide, and discusses the role of patient advocacy in shaping current approval processes. The chapter also examines the evolving dynamics of drug trials during the COVID-19 pandemic and the challenges faced in pharmaceutical development amidst changing priorities.

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