Aug 3, 2015
FDA Approved Drugs under the Animal Rule
FDA Approved Drugs under the Animal Rule
United States Food and Drug Administration (FDA) The Animal Rule
It commonly refers to the regulations that set forth the pathway for approval of these products under 21 CFR 314.600 (drugs) or 21 CFR 601.90 (biological products).
Animal Rule Summary
In assessing the sufficiency of animal data, the agency may take into account other data, including human data, available to the agency. Under this…
View On WordPress