@misc{511, author = {U.S. Food & Drug Administration}, title = {Animal Rule Information}, abstract = {The Animal Rule may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible}, year = {2024}, number = {2022-12-01}, month = {2024-03-25}, url = {https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/animal-rule-information}, language = {en}, }