FDA Releases Draft Guidance on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act

Summary

The Food and Drug Administration (FDA) has published a draft guidance outlining its procedures for handling citizen petitions and petitions for stay of action under the Federal Food, Drug, and Cosmetic Act, which was amended in 2007 to address these types of petitions.