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U.S. Department of Health and Human Services

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Number of core initial promotional campaign material reviews completed in the month

Dictionary: “Launch” materials are the initial promotional materials that companies disseminate to healthcare professionals and consumers after FDA approves a new drug (or approves a new use for a drug). FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs. The “core” launch materials are those that contain the key messages that will be used throughout the launch campaign, as well as representative examples of other important disclosures, such as risk information, for the advertised product. By reviewing and providing advisory comments on core launch campaigns in a timely manner, OPDP can positively influence the initial marketing messages that companies disseminate about their new products and help ensure that the public receives accurate and balanced information about new prescription drugs. Because this is a program measure (i.e., a measure that focuses on the OPDP program area), the time required for consultation outside of OPDP (if any) on launch campaigns is being subtracted out of the overall review time. As a result, the measure is reflective of the time it takes to review these materials within OPDP rather than the total agency review time.

Information is current as of December 31, 2017.

Fiscal Year - 2016

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TimeTargetNumber
Oct 2015N/A5
Nov 2015N/A9
Dec 2015N/A13
Jan 2016N/A10
Feb 2016N/A16
Mar 2016N/A16
Apr 2016N/A9
May 2016N/A16
Jun 2016N/A7
Jul 2016N/A10
Aug 2016N/A9
Sep 2016N/A4

FY 2016 Total: 124

Footnotes

  • The FDA’s goal is to provide comments on draft “core launch” promotional materials within 45 days of the voluntary submission of these materials by sponsors. However, some recent draft core launch promotional materials submitted for voluntary review have raised complex issues that required additional review, resulting in review times that exceeded the 45 day goal. While review timeframes for certain submissions may require more than 45 days in the immediate future, the FDA is working hard to review the majority of submissions within 45 days and to achieve overall completion percentages that are similar to those observed in the past. Sponsors are encouraged to contact the FDA with any questions and to temporarily build in additional review time for their materials.

Percentage of completed reviews of core initial promotional campaign materials performed within 45 days, subtracting out the time period of medical consultation, if any, from overall review time

Fiscal Year - 2016

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TimeTargetPercentage
Oct 2015N/A100
Nov 2015N/A89
Dec 2015N/A54
Jan 2016N/A10
Feb 2016N/A56
Mar 2016N/A44
Apr 2016N/A67
May 2016N/A50
Jun 2016N/A43
Jul 2016N/A90
Aug 2016N/A67
Sep 2016N/A75

FY 2016 Overall: 58%

Footnotes

  • The FDA’s goal is to provide comments on draft “core launch” promotional materials within 45 days of the voluntary submission of these materials by sponsors. However, some recent draft core launch promotional materials submitted for voluntary review have raised complex issues that required additional review, resulting in review times that exceeded the 45 day goal. While review timeframes for certain submissions may require more than 45 days in the immediate future, the FDA is working hard to review the majority of submissions within 45 days and to achieve overall completion percentages that are similar to those observed in the past. Sponsors are encouraged to contact the FDA with any questions and to temporarily build in additional review time for their materials.

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.

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