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U.S. Department of Health and Human Services

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Browse FDA-TRACK Program Areas or Center for Drug Evaluation and Research Index

Increase the number of Office of Generic Drugs (OGD) meetings with industry to provide guidance

Dictionary: Providing guidance to industry using a variety of mechanisms is intended to assist with the development of high quality, generic drug products by a number of potential manufacturers. Guidance in the form of meetings is especially valuable for developing more complex products such as dry powder inhalers or topical products for which generics are not currently available. FDA’s scientific guidance documents are intended to maximize both industry and OGD resources by minimizing less than optimal product development and applications that cannot be approved.


These measures have 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 - 2012

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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A0
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 0

Increase the number of presentations to external organizations

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A0
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 0

Number of guidances initiated

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A0
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 0

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.