REMS Audits

Risk Evaluation & Mitigation Strategy (REMS) are required by the FDA for drugs that carry serious safety concerns and are designed to ensure the benefits of the medication outweigh the risks.  The goal is to reduce the occurrence and/or severity of medication risks by supporting the use conditions described in the FDA approved labeling.  REMS was introduced with the FDA Amendments Act of 2007 (FDAAA).  Globiox auditors can help ensure that a company’s REMS meets the requirements of FDAAA.