• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

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, 2014

Fiscal Year - 2013

Skip graphic and jump to text data

TimeTargetPercent
October – December 201290100
January – March 201390100
April – June 201390100
July – September 201390100

FY 2013 Total: 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 - 2013
Skip graphic and jump to text data.

TimeTargetNumber
October – December 2012N/A12
January – March 2013N/A9
April – June 2013N/A11
July – September 2013N/A18

FY 2013 Total: 50

Number of approval letters that were posted on time (within 5 business days, excluding days WCMS is not operational) during the quarter.

Fiscal Year - 2013
Skip graphic and jump to text data.

TimeTargetNumber
October – December 2012N/A12
January – March 2013N/A9
April – June 2013N/A11
July – September 2013N/A18

FY 2013 Total: 50

Number of approval letters that were not posted within 5 business days, excluding days that WCMS is not operational.

Fiscal Year - 2013
Skip graphic and jump to text data.

TimeTargetNumber
October – December 2012N/A0
January – March 2013N/A0
April – June 2013N/A0
July – September 2013N/A0

FY 2013 Total: 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.