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 September 30, 2021
Fiscal Year - 2021
Time | Target | Percent |
---|---|---|
Oct - Dec 2020 | N/A | 100 |
Jan - Mar 2021 | N/A | 100 |
Apr - Jun 2021 | N/A | 100 |
Jul - Sept 2021 | N/A | 100 |
FY 2021 Total: 100%
Footnotes
- (1) This measure was tracked monthly from January 2010 through September 2012, and tracked quarterly from October 2012 through present.
Number of approval letters provided to OCOD for posting this quarter.
Fiscal Year - 2021
Time | Target | Number |
---|---|---|
Oct - Dec 2020 | N/A | 13 |
Jan - Mar 2021 | N/A | 32 |
Apr - Jun 2021 | N/A | 23 |
Jul - Sept 2021 | N/A | 24 |
FY 2021 Total: 92
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.