About FDA
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 - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 8 |
| Nov 2009 | N/A | 2 |
| Dec 2009 | N/A | 0 |
| Jan 2010 | N/A | 7 |
| Feb 2010 | N/A | 2 |
| Mar 2010 | N/A | 0 |
| Apr 2010 | N/A | 4 |
| May 2010 | N/A | 0 |
| Jun 2010 | N/A | 1 |
| Jul 2010 | N/A | 1 |
| Aug 2010 | N/A | 0 |
| Sep 2010 | N/A | 0 |
FY 2010 Total: 25
Increase the number of presentations to external organizations
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 16 |
| Nov 2009 | N/A | 1 |
| Dec 2009 | N/A | 0 |
| Jan 2010 | N/A | 1 |
| Feb 2010 | N/A | 2 |
| Mar 2010 | N/A | 5 |
| Apr 2010 | N/A | 8 |
| May 2010 | N/A | 4 |
| Jun 2010 | N/A | 0 |
| Jul 2010 | N/A | 0 |
| Aug 2010 | N/A | 0 |
| Sep 2010 | N/A | 1 |
FY 2010 Total: 38
Number of guidances initiated
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 1 |
| Nov 2009 | N/A | 0 |
| Dec 2009 | N/A | 0 |
| Jan 2010 | N/A | 0 |
| Feb 2010 | N/A | 0 |
| Mar 2010 | N/A | 1 |
| Apr 2010 | N/A | 0 |
| May 2010 | N/A | 0 |
| Jun 2010 | N/A | 0 |
| Jul 2010 | N/A | 0 |
| Aug 2010 | N/A | 0 |
| Sep 2010 | N/A | 0 |
FY 2010 Total: 2
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.
