In 2007, a new law was enacted that provided the FDA many new authorities and responsibilities to enhance drug safety. The new law is termed the Food and Drug Administration Amendments Act- sometimes referred to as “FDAAA”- and one of its provisions gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. A drug’s sponsor develops the REMS and the FDA reviews and approves it. A REMS is uniquely tailored to the risks associated with a specific drug or class of drugs (ie: no two REMS will be identical). REMS are also mandated to be patient-centric.
A REMS may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use. Since medicines are very different from each other, each REMS for each medicine is also different. REMS elements can include a Medication Guide (MG) or Patient Package Insert, a Communication Plan, Elements to Assure Safe Use (ETASU), and an Implementation Plan. REMS must include a timetable for submission of assessments.
A given REMS may or may not include an ETASU. ETASU are required medical interventions or other actions healthcare professionals must execute prior to prescribing or dispensing a drug to a patient. In some cases, ETASU actions may also be required for the patient to continue on treatment with the medication.
Often, skilled resources and Quality expertise are not available to understand the regulatory requirements for developing, implementing and managing a compliant REMS program. Kymanox’s broad expertise in identifying and implementing efficient, effective and sustainable policies, processes and procedures will ensure your REMS program includes all of the necessary compliance elements to meet the satisfaction of the internal and external customers it supports and serves, along with meeting the compliance requirements and rigors of today’s regulatory environment.
KymanoxWORKS offers a Risk Management Process SOP Package.
For more information, please view the packages at our store.