FDA Removes Obsolete Draft Guidances

May 11, 2015

The FDA has withdrawn at least 10 draft guidances for drugmakers published before the end of 2013 because they had become outdated or were superseded by higher agency priorities.

The drug and biologics guidances, part of a larger list of 47 draft guidances published between 1997 and 2012, cover such topics as notification to FDA of potential shortages and considerations for providing regulatory submissions in electronic format. The list was published in the Federal Register.

In a March 9 letter to Senate HELP Committee Chairman Lamar Alexander, the FDA noted that the median number of days to finalize CBER guidance is 743 days. For CDER guidance, the track record is only slightly better at 710 days.

The agency is accepting comments through June 4 at docket no. FDA-2015-N-1419. View the notice on Withdrawal of Draft Guidance Documents Published Before December 31, 2013 at www.fdanews.com/5-15-FDA-Withdrawals.pdf. — Jonathon Shacat and Elizabeth Orr