FDA Releases Guidance on Self-Selections Studies
FDA Releases Guidance on Self-Selections Studies
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.
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
