BioCentury
ARTICLE | Politics & Policy

FDA reports delays in finalizing draft guidances

March 11, 2015 1:34 AM UTC

FDA sent a letter to Senate Health, Education, Labor and Pensions (HELP) Committee chair Sen. Lamar Alexander (R-Tenn.) detailing the agency's record of finalizing draft guidance documents. The agency listed 171 draft guidances published before Dec. 31, 2013, that have not been finalized. FDA also reported that it took the Center for Drug Evaluation and Research (CDER) an average of 710 days to move from draft to final versions, among final guidances published between June 1, 2009, and June 30, 2014. The Center for Devices and Radiological Health (CDRH) averaged 797 days; the Center for Biologics Evaluation and Research (CBER) averaged 743.

Alexander and colleagues requested the information last May. FDA noted that extensive resources are required to finalize draft guidances, including reviewing public comments and sometimes seeking additional public input through meetings and workshops, and that experts who write and review guidance documents are also working on product reviews under statutory deadlines. FDA also said final guidances should be based on up to date science, and reported that in "areas of rapid scientific or regulatory development, this need to ensure that the final guidance is current and most useful to the regulated community may prompt us to delay completing a final guidance until our recommendations can stabilize." ...