The FDA and the institute have collaborated on the project since 2016, focusing on rapid information sharing and case analysis when adverse events arise. Over the years, the agency has collected and evaluated cases to provide safety information and identify new signals for product labeling.
Signal information refers to data suggesting a new potential causal relationship — or a new aspect of a known association — between a drug and an adverse event. Obtained from one or more sources, the data is considered worthy of further analysis and is not limited to harmful relationships.
This year, the FDA plans to intensify its evaluation of bio-pharmaceutical adverse events. The agency will also develop and distribute pamphlets and guidelines to help healthcare providers educate patients on the proper use of self-injectable medications in clinical settings.
