Posted by Michael Wonder on 09 Nov 2017
FDA is making it easier to meet required extra safety measures for certain FDA approved drugs
8 November 2017 - For some FDA approved drugs specific safety steps must be taken before the patient can receive the medication.
These measures, which may involve the patient, health care providers and manufacturers, are part of an FDA-required program called a risk evaluation and mitigation strategy (REMS). They are specifically designed to help ensure that the benefits of a prescription drug outweigh its risks.
As an example, if a drug has a known risk for causing birth defects, a REMS program might require that a patient be asked her pregnancy status before beginning that drug, information that the health care provider documents in her health record.
