When it comes to regulatory decision-making, the FDA places significant emphasis on the relevance and reliability of registry data, as highlighted by Pallavi Mishra-Kalyani, deputy director of the Division of Biometrics at the Center for Drug Evaluation and Research (CDER) at the FDA.
Registry data play a crucial role in informing regulatory decisions, and the FDA's thorough evaluation process ensures that only data that are fit for purpose are utilized in decision-making.
By considering factors such as data relevance and reliability, the FDA aims to maintain high standards in regulatory decision-making processes, ultimately prioritizing the safety and efficacy of drugs and medical products.