FDA has released recommendations on the development and conduction of self-selection studies in support of applications for nonprescription drug products. Guidance for Industry, Self-Selection Studies for Nonprescription Drug Products provides general principles related to “the conduct of self-selection studies, including study design, methodology, and analyses, and should not be considered a substitute for an FDA review of specific protocols.” The guidance incorporates advice from the Nonprescription Drugs Advisory Committee meeting on September 25, 2006. The committee considered issues related to analysis and interpretation of consumer studies conducted to support marketing of nonprescription drug products.
