The FDA Animal Rule and its role in protecting human safety
Author:
Affiliation:
1. Theresa Allio LLC, Millburn, NJ, USA
Publisher
Informa UK Limited
Subject
Pharmacology (medical),General Medicine
Link
https://www.tandfonline.com/doi/pdf/10.1080/14740338.2018.1518429
Reference3 articles.
1. US Food and Drug Administration. FDA Animal Rule regulations. Fed Regist. 67(105):Friday May 31 2002.
2. Product Development Under FDA’s Animal Rule: Understanding FDA’s Expectations and Potential Implications for Traditional Development Programs
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