FDA announces development of set of performance measures aimed at helping improve timeliness, predictability of review of certain types of tobacco products currently reviewed by agency

Nevin Barich

WASHINGTON , April 19, 2014 (press release) – Today, FDA is announcing the development of a set of performance measures that will help improve the timeliness and predictability of the review of certain types of tobacco products currently regulated by FDA.

FDA has established four performance measures and timeframes: for review of regular SE Reports, review of Exemption from SE Requests, review of Modified Risk Tobacco Product (MRTP) Applications, and for meeting requests. Beginning on October 1, 2014, all four measures will be implemented, meaning that FDA will start monitoring the time it takes to review and take action. The interim time between now and implementation, will be used to develop tracking systems for monitoring progress in meeting the performance goals. As FDA gains more experience with reviewing provisional SE Reports, we intend to identify and implement measures for these submissions as well.

Going forward, FDA will continue to strengthen and expand the review process, which will enable us to be well positioned to meet more ambitious performance standards in the future.

For a full look at the new measures and for more information about other tobacco product review activities, read our feature by CTP Director Mitch Zeller.

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