FDA Proposed Rule Addresses Citizen Petitions Involving ANDAs and Section 505(b)(2) New Drug Applications

On January 3, 2012, the Food and Drug Administration (FDA) issued a proposed rule to amend the regulations on Citizen Petitions and Petitions for Stay of Action (collectively referred to as Petitions), relating to requests for the FDA to take action on a pending drug application submitted under section 505(b)(2) or (j) of the Federal Food, Drug, and Cosmetic Act (FDC Act).1 The proposed rule would implement section 505(q) of the FDC Act, 21 U.S.C. § 355(q), which was added as part of the Food and Drug Administration Amendments Act of 2007 in response to Congressional concerns that petitions submitted late in the drug application review process were resulting in the improper delay of drug approvals.

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