The US Food and Drug Administration’s latest regulatory goals update includes October as the target date for publishing final rules on moving more drug ingredients to OTC and on exemptions from investigational new drug clearance for clinical trials to evaluate food, dietary supplements or cosmetics.
ACNU Switch And IND Exemption Final Rules Targeted For October In FDA Regulatory Goals
Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.
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