CDER SBIA Update: Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy

Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy

Today, the FDA published a new guidance for industry, “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act--Compliance Policy.” This guidance describes FDA’s compliance policy regarding certain requirements in the Federal Food, Drug, and Cosmetic Act for trading partners engaged in transactions with first responders, and is in effect until further notice by the Agency.