FDA Releases Draft Guidance for Section 505G of Food, Drug, and Cosmetic Act

FDA published guidance on June 13, 2023 providing recommendations for industry and review staff on the formal disagreement resolution and administrative hearings procedures for resolving scientific and/or medical disputes between the Center for Drug Evaluation and Research (CDER) and requestors and sponsors of drugs that are subject to a final administrative order under section 505G of the Food, Drug, and Cosmetic Act.

According to the guidance, nonprescription drugs are covered without approved new drug applications, which are governed by the provisions of section 505G. Additionally, the guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.

The guidance outlines the procedures for an administrative hearing related to a final order and describes the procedures for consolidated proceedings for FDR and hearings to resolve scientific and/or medical disputes related to final orders.

Source: FDA