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OBJECTIVE:

The objective of this Circular is to provide guidelines for the use of the new FDA eServices Portal System for LTO applications of Drug Distributors (Drug Wholesalers, Exporters, and Importers), Drug Traders, Drug Retailers (Drugstores and RONPD), CRO, and Sponsors.

Please email your comments at [email protected] . Deadline for accepting comments will be on 10 August 2020 until 12:00 PM.

Attachment:-> Draft Guidelines for the Use of the FDA eServices Portal for LTO Application