Fulfilling the Mandate of the US Food and Drug Administration's Accelerated Approval Pathway: The Need for Reforms

JAMA Intern Med. 2021 Oct 1;181(10):1275-1276. doi: 10.1001/jamainternmed.2021.4604.

Authors

Bishal Gyawali¹, Joseph S Ross², Aaron S Kesselheim³

Affiliations

¹ Departments of Oncology and Public Health Sciences, Queen's University, Kingston, Ontario, Canada.
² Section of General Medicine and the National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
³ Program On Regulation, Therapeutics and Law (PORTAL), Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

PMID: 34254981
DOI: 10.1001/jamainternmed.2021.4604

No abstract available

Publication types

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

MeSH terms

Biomarkers
Biomarkers, Pharmacological
Clinical Trials as Topic
Drug Approval* / methods
Drug Approval* / organization & administration
Drug Evaluation* / methods
Drug Evaluation* / trends
Drug and Narcotic Control* / legislation & jurisprudence
Drug and Narcotic Control* / methods
Drug and Narcotic Control* / trends
Drugs, Investigational / pharmacology*
Humans
Medical Oncology / methods
Needs Assessment
Product Surveillance, Postmarketing / methods
Product Surveillance, Postmarketing / standards
Risk Assessment* / methods
Risk Assessment* / trends
Treatment Outcome
United States

Substances

Biomarkers
Biomarkers, Pharmacological
Drugs, Investigational