Pink Sheet Podcast: The Most Impactful Stories Of 2019
Pink Sheet reporters review the major issues that emerged during the past year and how they will impact 2020.
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Investigators should plan to find the vital status of discontinued patients, guidances states. Participants need frequent reminders to complete PRO instruments, agency recommends.
Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.
US FDA officials fear comparator arms would be unwieldy for ongoing trials as they consider alternative methods to measure efficacy if placebo controls can't be maintained for the studies of other candidate vaccines once a product is on the market.