New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels.

ABSTRACT:

Background

The FDA Patient-Focused Drug Development Initiative was launched to ensure the incorporation of the patient voice into drug development and evaluation. Since 2017, the FDA must publish a statement outlining patient experience data (PED) considered in the approval of new drugs. This study investigated the presence and role of PED in drug approval and translation into product label claims.

Methods

PED reported in approval packages of the 48 drugs approved by FDA's Center for Drug Evaluation and Research in 2019 was identified and categorized. PED in the form of clinical outcome assessments (COAs) was characterized by endpoint positioning and outcome. The product labels were analyzed for PED-related claims.

Results

PED was reported as relevant for 39 of 48 (81

SUBMITTER: Schultz-Knudsen K 

PROVIDER: S-EPMC8021513 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature