Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984–2018: an evaluation of Food and Drug Administration flexibilities

  04 June 2020

Antimicrobial resistance is of growing concern. To encourage development of new treatments, some commentators have suggested regulators exercise increased flexibility on the clinical evidence required for approval. We examined all 1065 new drugs and biologics approved by the US Food and Drug Administration between 1984 and 2018 and recorded each drug’s use of the Orphan Drug Act, fast-track, priority review, accelerated approval, and breakthrough therapy programmes, as well as dates of investigational new drug application, new drug application, and new drug approval, which were used to calculate clinical development and review times.

Author(s): Jonathan J Darrow, SJD Mehdi Najafzadeh, PhD Kristina Stefanini, BA Prof Aaron S Kesselheim, MD
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