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U.S. Department of Health and Human Services

About FDA

Number of efficacy supplements received in the quarter (1)

Dictionary: Efficacy Supplements to New Drug Applications (NDAs), Biologics License Applications (BLAs), Post Marketing Application (PMA) Panel Track, Abbreviated New Drug Application (ANDAs) and Biosimilar Biological Product Applications (BBPAs) are submissions that will make a change to an approved marketing application. This change may include a new or expanded indication, new routes of administration, revisions to the dosage or dosing regimen, or improved safety. This measure track’s CBER’s performance in issuing decisions within established timeframes.

Information is current as of September 30, 2014

Fiscal Year - 2013

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TimeTargetNumber
October – December 2012N/A5
January – March 2013N/A1
April – June 2013N/A9
July – September 2013N/A5

FY 2013 Total: 20

Footnotes

  • (1) Beginning October 2012, this measure will be reported quarterly

Number of overdue efficacy supplements at the end of the quarter (1)

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

FY 2013 Total: 0

Footnotes

  • (1) Beginning October 2012, this measure will be reported quarterly.

Number of actions taken on efficacy supplements during the quarter (1) (2)

Dictionary: Efficacy Supplements to New Drug Applications (NDAs), Biologics License Applications (BLAs) and Post Marketing Application (PMA) Panel Track are applications to make a change to an approved marketing application. This change may include new indications, new routes of administration, new dosage forms, or improved safety. This measure track’s CBER’s performance in issuing decisions within established timeframes.

Fiscal Year - 2013

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TimeTargetNumber
October – December 2012N/A1
January – March 2013N/A5
April – June 2013N/A3
July – September 2013N/A7

FY 2013 Total: 16

Footnotes

  • (1) Beginning October 2012, this measure will be reported quarterly
  • (2) Actions include approval, denial, refusal to file, withdrawal, and complete response for BLAs and NDAs, additional information, determination of substantially equivalent, determination of not substantially equivalent for 510(k)s, and approval, approvable, not approvable, withdrawal, denial, refusal to file and major deficiency for PMAs.

Number of actions taken on efficacy supplements in the month that were within goal dates (1) (2)

Fiscal Year - 2013
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TimeTargetNumber
October – December 2012N/A1
January – March 2013N/A5
April – June 2013N/A3
July – September 2013N/A7

FY 2013 Total: 16

Footnotes

  • (1) Beginning October 2012, this measure will be reported quarterly
  • (2) Actions include approval, denial, refusal to file, withdrawal, and complete response for BLAs and NDAs, additional information, determination of substantially equivalent, determination of not substantially equivalent for 510(k)s, and approval, approvable, not approvable, withdrawal, denial, refusal to file and major deficiency for PMAs.

Number of actions taken on efficacy supplements in the month that were past goal dates (1) (2)

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

Footnotes

  • (1) Beginning October 2012, this measure will be reported quarterly
  • (2) Actions include approval, denial, refusal to file, withdrawal, and complete response for BLAs and NDAs, additional information, determination of substantially equivalent, determination of not substantially equivalent for 510(k)s, and approval, approvable, not approvable, withdrawal, denial, refusal to file and major deficiency for PMAs.

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.