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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

The FDA Law Blog

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.

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The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

The National Institutes of Health reports that in 2012, $418 billion was wasted in the US due to suboptimal use of medications. Medically integrated pharmacy (MIP) interventions using data from a cost avoidance and waste tracker tool show: The net cost avoidance for the MIPs was $6,510,971.28 compared with $546,082.45

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Levonorgestrel Intrauterine Device for Emergency Contraception

Birth Control Pharmacist

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 medical records 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.