Work

Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation

Year: 2016

Type: article

Abstract: This survey study examines how well physicians understand the US Food and Drug Administration’s (FDA’s) statutory definition of a “breakthrough” therapy, and whether the term breakthrough affects their perceptions of a drug’s efficacy.

Source: JAMA

DOI: 10.1001/jama.2015.16984

Authors: Aaron S. Kesselheim, Steven Woloshin, Wesley Eddings, Jessica M. Franklin, Kathryn M. Ross, Lisa M. Schwartz

Institutions: Brigham and Women's Hospital, Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth–Hitchcock Medical Center, American Board of Internal Medicine

Language: English

Topic: Pharmaceutical industry and healthcare

Subfield: Pharmacology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: bronze

OpenAlex ID: W2338811205