… and approval process of drugs for serious unmet needs, four … transfer, hold great promise for
addressing unmet medical needs [1]… , two drug withdrawals, and three drug label changes or …

… A commitment to train personnel and to change the … standing, regulatory hurdles aligning
with FDA requirements, and … holds great promise for advancing precision medicine [138,139]. …

… The promises are genuinely fueling a fundamental … a book that changed the way we think
about the environment, how a … ailment and develop a drug that everyone who had that ailment …

… data sets needed to mitigate pitfalls in the journey of a drug from … modeling tools has shown
promise for increasing the … can be re-evaluated as modifications are made to the advanced …

… Customize your JAMA Network experience by selecting one … to update its own materials in
response to a change by FDA. … when there is a serious unmet health need, but the Makena …

… that may be more sensitive to change could complement existing … Despite the promise of
the digital revolution in healthcare, … area associated with growing unmet need due to our aging …

… genetic level, polygenic risk scores hold promise to predict genetic … -needed-to-treat and/or
to spare patients exposure to drugs … to advance precision/personalized medicine approaches. …

… have high unmet needs for personalized medicine from the … clinical trials, and show promise
as potential therapeutic agents … of therapeutic drugs that radically change the progression of …

… The concept of personalized medicine—selecting the … serious unmet medical needs has
highlighted the need for a shift … license, and indicate if changes were made. The images or other …

… through investment in expensive, customized technology platforms, like … of change indicates
the extent of our readiness to embrace the revolution needed to create a dynamic regulatory …