Expanded access to investigational drugs.

New England Journal of Medicine

PubMedID: 25839859

Lurie P, Chan-Tack KM, Woodcock J. Expanded access to investigational drugs. N Engl J Med. 2015;372(15):1473-4.
To the Editor: Darrow et al. (Jan. 15 issue)(1) highlight the challenges posed by expanded patient access to unapproved drugs, including an application process that may have been complicated by the time and complexity for physicians to complete the form currently used by the Food and Drug Administration (FDA) and multiple associated documents. (2) On February 4, 2015, the FDA published draft guidance on a streamlined process for individual-patient expanded-access submissions by physicians treating single patients with investigational drugs. (3) The process continues to protect patients while not undermining clinical-trial enrollment. Feedback from academia, physicians, patients, advocacy groups, and industry helped the. . .