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U.S. Department of Health and Human Services

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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.

Dictionary: OPDP is tracking the percentage of advisory reviews of core launch campaigns for prescription drugs that it completes within 45 days, subtracting out the time period of medical consultation, if any, from the overall review time. “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.

These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2011

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Oct 2010N/A75
Nov 2010N/A100
Dec 2010N/A100
Jan 2011N/A92
Feb 2011N/A100
Mar 2011N/A75
Apr 2011N/A100
May 2011N/A100
Jun 2011N/A100
Jul 2011N/A100
Aug 2011N/A100
Sep 2011N/A85

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

Fiscal Year - 2011
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Oct 2010N/A8
Nov 2010N/A12
Dec 2010N/A10
Jan 2011N/A12
Feb 2011N/A10
Mar 2011N/A8
Apr 2011N/A6
May 2011N/A9
Jun 2011N/A10
Jul 2011N/A12
Aug 2011N/A6
Sep 2011N/A13

FY 2011 Total: 116


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.