Expanded Access as a source of real‐world data: An overview of FDA and EMA approvals
Author:
Affiliation:
1. Department of Biostatistics Erasmus Medical Center Rotterdam The Netherlands
2. Erasmus School of Health Policy & Management Erasmus University Rotterdam Rotterdam The Netherlands
3. RWD Department myTomorrows Amsterdam The Netherlands
Funder
myTomorrows
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14284
Reference42 articles.
1. Pre-approval Access Terminology: A Cause for Confusion and a Danger to Patients
2. The FDA's New Procedures for the Use of Investigational Drugs in Treatment
3. Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs
4. An overview of Compassionate Use Programs in the European Union member states
5. Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period
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