JAMA Forum: The Risks and Benefits of Expedited Drug Reviews image

JAMA Forum, May 23, 2018
Austin Frakt, citing paper co-authored by Jonathan J. Darrow (Student Fellow Alumnus)

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Read the cited paper

From the article:

The US Food and Drug Administration (FDA) oversees several programs that expedite approval of certain drugs that treat serious conditions and address unmet medical needs. On average, a drug in an expedited program reaches market almost a year sooner than other drugs. However, expediting drug approvals raises concerns that important safety or effectiveness information will be missed, potentially heightening risk of patient harm.

Read more here and the cited paper here!

fda health law policy pharmaceuticals regulation