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Sentinel enhances the fda’s ability to proactively monitor the safety of medical products after they have reached the market and complements the agency’s existing adverse event reporting system. Sentinel was created to meet the mandate described in section 905 of the food and drug administration amendments act 2007 (fdaaa) to create an active postmarket drug safety surveillance system. Food and drug administration (fda) leads the sentinel initiative
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The main goal is to improve how fda evaluates the safety and performance of medical products. For information on current and completed medical product assessments conducted in the sentinel system by the center for drug evaluation and research (cder), please visit sentinel’s drug studies. Sentinel has the largest multisite distributed database in the world dedicated to medical product safety
It is constantly growing and improving to meet fda’s needs.
Fda created the sentinel initiative to meet a mandate by congress in the fda amendments act of 2007 Through the sentinel initiative, fda aims to develop new ways to assess the safety of approved medical products including drugs, vaccines, and medical devices. Sentinel initiative is a set of efforts by u.s Food and drug administration (fda) that tries to improve the ability to identify and evaluate safety of medicinal products
The sentinel initiative was launched in response to the food and drug administration act of 2007 (fdaaa) and congressional mandate that fda develop a national electronic system to track the safety of regulated medical products.
