FDA Offers Draft Guidance on E-Submissions of REMS Documents

The FDA recently released draft guidance describing how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications, abbreviated new drug applications and biologics license applications.
FDA Comments on Stakeholder Feedback
In the guidance, FDA describes three years of engagement and analysis of stakeholder feedback regarding REMS standardization. The agency’s findings were published as a report: “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS).” As the report describes, some stakeholders expressed concern about the clarity and consistency with which information about REMS materials and requirements are communicated to stakeholders. They told FDA that REMS materials and requirements may be difficult to locate, and that specific activities and requirements of various stakeholders (e.g., prescriber, pharmacist) are not always clearly outlined.
Some stakeholders expressed the need to have better ways to integrate REMS materials and procedures into their existing health information systems and health care delivery processes. Stakeholders also expressed the desire to avoid spending excessive time trying to locate, understand, and comply with different REMS requirements while ensuring safe use of drugs with REMS.
To help address these concerns, FDA intends to require applicants of NDAs, ANDAs, and BLAs to submit the conte...

Source: Policy and Medicine - December 5, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs