FDA notified the sponsor on November 1st that it would provide a written basis for the hold by “the due date of 11/15/19.”The complaint also alleges that FDA failed to comply with its regulations because the original email providing notice of the clinical hold did not “briefly explain the basis for the action,” as required by 21 C.F.R. § 312.42(d). The same regulation also provides that within 30 days after imposition of the hold, the Division Director will provide the sponsor a written explanation of the basis of the hold.