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The general drug development process is laboratory research preclinical research, including animal testing and basic safety tests clinical research, also known as human trials review, in which the FDA decides whether to approve the new drug post-marketing safety monitoring Using the information gathered from this process, the FDA will decide whether a drug requires a boxed warning

Published research on OTC weight loss supplements typically involves small sample sizes (50200 participants), short duration (812 weeks), and often lacks rigorous control groups