FDA still is categorizing ingredients in its existing OTC drug monograph program so it would hit the ground running if Congress passes legislation to dramatically streamline its process for deciding whether an ingredient, indication or dosage format is generally regarded as safe and effective, says Theresa Michele, the agency's nonprescription drug products chief.
At the Consumer Healthcare Products Association’s Regulatory, Scientific & Quality Conference in Washington on May 18, Michele said assigning monograph categories to 800 OTC active ingredients for more than 1,400...