Integration of Paper Label Applications into the Label Submission and Approval System (LSAS)
Form guidance for the paper submissions of label applications and the integration into the Label Submission and Approval System (LSAS).
Extraordinary Circumstances - Procedures for Evaluating Labeling
Provides guidance on requests for accelerated label evaluations for temporary approvals only.
Labeling Conditions That Can Not Have a Temporary Approval
Outline of situations in which label applications may not receive temporary approval.
Procedures for Labeling Evaluation Submissions and Policy Advisory Consultations
Last Updated: Jul 24, 2020