FDA Good ANDA submission practices Jan-2018 draft [Regulatives / Guidelines]

posted by nobody – 2018-01-18 16:11 (2370 d 12:57 ago) – Posting: # 18210
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Whole Section "VI BE deficiencies"


Kindest regards, nobody

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One can show the following: given any rule, however “fundamental”
or “necessary” for science, there are always circumstances
when it is advisable not only to ignore the rule,
but to adopt its opposite.    Paul Feyerabend

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