The FDA Breakthrough-Drug Designation - Four Years of Experience

N Engl J Med. 2018 Apr 12;378(15):1444-1453. doi: 10.1056/NEJMhpr1713338.

Authors

Jonathan J Darrow¹, Jerry Avorn¹, Aaron S Kesselheim¹

Affiliation

¹ From the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston.

PMID: 29641970
DOI: 10.1056/NEJMhpr1713338

No abstract available

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Anti-Infective Agents / therapeutic use
Clinical Trials as Topic / methods
Drug Approval / legislation & jurisprudence
Drug Approval / statistics & numerical data*
Drug Discovery
Drug Industry / statistics & numerical data*
Drugs, Investigational / therapeutic use*
Humans
Investigational New Drug Application / legislation & jurisprudence
Neoplasms / drug therapy
Rare Diseases / drug therapy
United States
United States Food and Drug Administration*

Substances

Anti-Infective Agents
Drugs, Investigational