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U.S. Department of Health and Human Services

About FDA

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 to the Office of New Drugs (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 March 31, 2014.

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A7
Nov 2012N/A10
Dec 2012N/A15
Jan 2013N/A12
Feb 2013N/A5
Mar 2013N/A11
Apr 2013N/A8
May 2013N/A14
Jun 2013N/A7
Jul 2013N/A8
Aug 2013N/A12
Sep 2013N/A9

FY 2013 Total: 118

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

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 - 2013

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TimeTargetPercentage
Oct 2012N/A86
Nov 2012N/A80
Dec 2012N/A100
Jan 2013N/A92
Feb 2013N/A100
Mar 2013N/A100
Apr 2013N/A100
May 2013N/A100
Jun 2013N/A72
Jul 2013N/A100
Aug 2013N/A100
Sep 2013N/A100

FY 2013 Overall: 95%

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

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.