Some Older Draft Guidances to Be Pulled, While Some Documents Will Be Finalized

The Food and Drug Administration is announcing an initiative in the Center for Drug Evaluation and Research (CDER) to review draft guidance documents issued before 2010 to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized, according to a notice published Aug. 7 in the Federal Register (78 Fed. Reg. 48,175).

Guidances that are no longer up to date, and for which more current information is available, will be withdrawn, FDA said. CDER will decide whether to revise or finalize guidances that reflect its current thinking.

The notice lists the first ...