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After attaining confluency around day 7, the inserts were turned upside down and placed into a sterile Petri dish and HULEC-5a cells (9 10 4 cells/cm 2 ) were added on the lower surface of transwell to develop co-culture system

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The FDA stated that this change in position was due to their belief that they do not have the legal regulatory authority to unilaterally declare a ban, citing concerns that any such ban would result in litigation that the FDA would lose

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