Shared REMS: FDA Explains Policies and Procedures
Posted 07 February 2019 | By
The US Food and Drug Administration (FDA) on Thursday posted a manual of policies and procedures (MAPP) explaining the policies, responsibilities and procedures by FDA for developing a single, shared system (SSS) risk evaluation and mitigation strategy (REMS).
More specifically, the MAPP deals with an SSS REMS with elements to assure safe use (ETASU) for a reference listed drug (RLD) and abbreviated new drug application (ANDA) that references the RLD during the review of the ANDA and for developing a separate REMS with ETASU (if applicable) for an ANDA during the review of the ANDA.
The 22-page MAPP lays out how and what parts of FDA work to create single, shared REMS systems, which can be complex and challenging to establish and run.
The MAPP builds on two guidance documents from last June that are designed to help industry navigate these challenges: Development of a Shared System REMS
and Waivers of the Single, Shared System REMS Requirement
. According to FDA, the latter guidance provides clarity to help alleviate delays in ANDA approvals that can be caused by prolonged negotiations over the development of a single, shared system REMS.
The MAPP, which CDER thought would be useful for staff and other interested parties, is a federal directive and documentation of internal policies and procedures that fulfills FDA’s obligation to maintain adequate systems of internal control for accounting and administrative activities. MAPPs are available
as part of transparency efforts under FDA’s Center for Drug Evaluation and Research.
Manual of policies and procedures