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Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice. Congress has recognized the challenges with FDA’s acceptance of RWD and RWE.
Participants were instructed to follow-up one month after IUD insertion for a urine pregnancy test, but even if they did not follow-up, their medicalrecords for the following six months were reviewed to verify if a pregnancy was ever detected. 2012; 27:1994-2000. Why the Levonorgestrel IUD? N Engl J Med. 2021; 384:335-44.
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