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U.S. Department of Health and Human Services

About FDA

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 - 2011

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TimeTargetNumber
Oct 2010N/A2
Nov 2010N/A1
Dec 2010N/A1
Jan 2011N/A0
Feb 2011N/A2
Mar 2011N/A0
Apr 2011N/A0
May 2011N/A0
Jun 2011N/A2
Jul 2011N/A2
Aug 2011N/A1
Sep 2011N/A1

FY 2011 Total: 12

Increase the number of presentations to external organizations

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A1
Nov 2010N/A2
Dec 2010N/A0
Jan 2011N/A0
Feb 2011N/A1
Mar 2011N/A0
Apr 2011N/A1
May 2011N/A1
Jun 2011N/A1
Jul 2011N/A0
Aug 2011N/A1
Sep 2011N/A1

FY 2011 Total: 9

Number of guidances initiated

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A1
Dec 2010N/A0
Jan 2011N/A0
Feb 2011N/A0
Mar 2011N/A0
Apr 2011N/A0
May 2011N/A0
Jun 2011N/A0
Jul 2011N/A0
Aug 2011N/A0
Sep 2011N/A0

FY 2011 Total: 1

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.