Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II.
cross_sectional · Level IV
Where this comes from
- Record sourced from PubMed, PMID 36069985.
- Also identified by DOI 10.1001/jamanetworkopen.2022.30530 and PMC identifier 9453539.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
This cross-sectional study examines drug approvals by the US Food and Drug Administration (FDA) Divisions of Neurology I and II to understand the role of clinical outcome assessments in regulatory decisions, including whether and how potential shortcomings are addressed.
Medical subject headings
- Drug Approval
- Neurology