Citizen Petitions Must Be Complete to Delay Drug Approvals

Petitioners seeking a delay in FDA approval of an ANDA must submit specific certifications, verifications and other materials with their petitions, the agency says in a draft guidance. The draft, published in the Jan. 21 Federal Register, proposes specifications that citizen petitions must meet when seeking a stay of approval under section 505(q) of the Food, Drug and Cosmetic Act for an ANDA submitted under section 505(j) or a drug submitted under section 505(b)(2).
Washington Drug Letter