" FDA will
hold a series of scientific meetings with
academic investigators, patient groups, drug
developers, statistical and methodological
experts, and ethicists to achieve a common
understanding of steps that can be taken when
an investigational drug being studied for a
serious disease with no acceptable treatment
option shows exceptional promise. CDER will
then publish a draft guidance on an expedited
development pathway based on the outcome
of these meetings."
Liking the way that paragraph reads :)
" FDA will hold a series of scientific meetings with academic...
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