About FDA
Percentage of approval letters reviewed for disclosure and posted on the web within 5 business days of receipt in OCOD, excluding days that the Web Content Management System (WCMS) is not operational. (1)
Dictionary: An approval letter is the document used to communicate CBER’s approval of original and supplemental biologics license applications (BLAs) or new drug application (NDAs). OCOD is responsible for ensuring CBER approval letters are reviewed for disclosure and posted on the agency's web site to conform to all pertinent requirements. Expedient posting of approval letters will provide up to date information to the public.
Information is current as of March 31, 2013
Fiscal Year - 2011
| Time | Target | Percent |
|---|---|---|
| Jan 2011 | 90 | 100 |
| Feb 2011 | 90 | 100 |
| Mar 2011 | 90 | 100 |
| Apr 2011 | 90 | 100 |
| May 2011 | 90 | 100 |
| Jun 2011 | 90 | 100 |
| Jul 2011 | 90 | 100 |
| Aug 2011 | 90 | 100 |
| Sep 2011 | 90 | 100 |
FY 2011 Overall: 100%
Footnotes
- (1) Beginning October 2012, this measure will be reported quarterly
Number of approval letters provided to OCOD for posting this quarter.
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Jan 2011 | N/A | 10 |
| Feb 2011 | N/A | 3 |
| Mar 2011 | N/A | 5 |
| Apr 2011 | N/A | 4 |
| May 2011 | N/A | 5 |
| Jun 2011 | N/A | 8 |
| Jul 2011 | N/A | 10 |
| Aug 2011 | N/A | 2 |
| Sep 2011 | N/A | 2 |
FY 2011 Total: 49
Number of approval letters that were posted on time (within 5 business days, excluding days WCMS is not operational) during the quarter.
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Jan 2011 | N/A | 10 |
| Feb 2011 | N/A | 3 |
| Mar 2011 | N/A | 5 |
| Apr 2011 | N/A | 4 |
| May 2011 | N/A | 5 |
| Jun 2011 | N/A | 8 |
| Jul 2011 | N/A | 10 |
| Aug 2011 | N/A | 2 |
| Sep 2011 | N/A | 2 |
FY 2011 Total: 49
Number of approval letters that were not posted within 5 business days, excluding days that WCMS is not operational.
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Jan 2011 | N/A | 0 |
| Feb 2011 | N/A | 0 |
| Mar 2011 | N/A | 0 |
| Apr 2011 | N/A | 0 |
| May 2011 | N/A | 0 |
| Jun 2011 | N/A | 0 |
| Jul 2011 | N/A | 0 |
| Aug 2011 | N/A | 0 |
| Sep 2011 | N/A | 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.
