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| 03 January 2012 | By Alexander Gaffney, RAC
On 3 January the US Food and Drug Administration (FDA) released a new proposed amendment via the US Federal Register that would amend the regulations governing the process for citizen petitions, petitions for stay of action, and the submission of documents to the FDA.
The proposed rule would amend the way the FDA deals with section 505(q) of the Federal Food, Drug and Cosmetic Act (FD&C Act), which regulates how the FDA responds to citizens petitions and petitions for stay of action (PSA) requests. Currently, the FDA uses these petitions to supplement and inform their thinking when it comes to the drug approval process.
Congress amended section 505(q) in 2007 under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to stop the use of such petitions to unnecessarily delay Abbreviated New Drug Approvals (ANDAs) or drugs submitted via the 505(b)(2) approval pathway.
Under FDAAA, the FDA must respond to petitions no later than 180 days after initial receipt of the petition (30 for PSA requests). In addition, if the FDA determines that a petition's primary purpose is to delay the approval of an application by raising invalid scientific or regulatory concerns, it can be dismissed at any time.
This proposed amendment:
Comments on the proposed amendments are due by 2 April, 2012.
Tags: Petition for Stay of Action, PSA, Citizen Petition, Proposed Amendment, Latest News, submission