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U.S. Department of Health and Human Services

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Percentage of 505(q) petition responses due in the month, completed by deadline

Dictionary: Section 914 of the Food and Drug Administration Amendments Act added new section 505(q) to the Federal Food, Drug, Cosmetic Act (the Act). Section 505(q) governs certain citizen petitions and petitions for stay of agency action that request that FDA take any form of action related to a pending application submitted under section 505(b)(2) or 505(j) of the Act. Under section 505(q)(1)(F) of the Act, FDA shall take final agency action on a petition subject to section 505(q) not later than 180 days after the date on which the petition is submitted.


These measures has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2010

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TimeTargetPercent
Oct 2009100100
Nov 2009100100
Dec 2009100100
Jan 2010100100
Feb 2010100100
Mar 2010100100
Apr 2010100100
May 2010100100
Jun 2010100100
Jul 2010100100
Aug 2010100100
Sep 2010100-

505(q) petition responses due during the month

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A1
Nov 2009N/A1
Dec 2009N/A2
Jan 2010N/A5
Feb 2010N/A4
Mar 2010N/A1
Apr 2010N/A1
May 2010N/A2
Jun 2010N/A2
Jul 2010N/A1
Aug 2010N/A4
Sep 2010N/A0

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.