Statement on improving adverse event reporting of compounded drugs to protect patients

Sep 9, 2019 – Compounded drugs can serve an important medical need for certain patients, however, they also present risks to patients since they are not evaluated by the FDA for safety, effectiveness and quality. The FDA’s compounding program aims to help protect patients from poor-quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them. Along with the development of policy and enforcement … (leggi tutto)