What it does is initiate a formal rulemaking process under the Federal Food, Drug, and Cosmetic Act in which the FDA must publish a proposed rule, accept public comment typically for 60 to 90 days and issue a final determination
Standard subcutaneous injection sites include the abdominal area (at least 2 inches from navel), thighs, and upper arms
Mixing an approved drug with an investigational compound is the standard safety position
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New food industry, 2016, 58 33-37.) 3