
Minor Dosage Form Changes to OTC Monograph Products Contemplated by Draft FDA Guidance
Today, the FDA published a draft guidance titled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs (here). This document discusses the conditions under which minor changes in dosage form (i.e., tablet or capsule to chewable tablets, orally disintegrating tablets (ODT), […]