Zdrowie i gospodarka · 20.12.2011

Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments

The Food and Drug Administration (FDA) is seeking comments on specific issues related to its authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require or order safety labeling changes for approved prescription drug products based on new safety information that becomes available after a drug product is approved. The FD&C Act specifies the timeframes within which a safety labeling change must be submitted when required or ordered by the FDA, and timeframes for FDA to conclude its review and take regulatory action regarding safety labeling changes. FDA's regulations also provide procedures by which labeling changes that do not qualify as changes based on new safety information can be requested by FDA or by the holder of the drug approval. FDA is seeking public input to assist the Agency in establishing specific timeframes for implementing both types of labeling changes.