Understanding CDER’s Postmarket Safety Surveillance Programs and Public Data

https://www.fda.gov/drugs/cder-conversations/understanding-cders-postmarket-safety-surveillance-programs-and-public-data?utm_medium=email&utm_source=govdelivery FDA maintains a system of postmarket surveillance and risk assessment programs to identify and evaluate adverse drug reactions and medication errors that did not appear during the drug development process, and to learn more about known adverse drug reactions. As part of this effort, the agency receives and analyzes reports of adverse events – problems that patients have after they take a drug regardless of whether the drug caused the event or not – to determine if these adverse events were caused by a drug. CDER uses these reports, along with other sources of drug safety data, to monitor the safety of approved drugs and therapeutic biologic products. When new potential safety issues are identified, FDA conducts a thorough and rigorous review of the available data before determining what, if any, actions are appropriate.