Big Molecule Watch
June 21, 2016

FDA Withdraws Previous Notice Seeking Comments on Proposed Biologic Naming Guidance

Earlier this month we reported that FDA had published a notice in the Federal Register soliciting comments on a proposed biologic naming guidance whereby applicants for biologic products would submit up to 10 proposed four-letter suffixes and, optionally, analyses supporting those suffixes.

FDA has now announced that it is withdrawing that notice.  The withdrawal notice is scheduled to be published in the Federal Register tomorrow.  An FDA spokesman has been quoted as calling the original notice’s publication an “administrative error.”