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Friday, 01/02/2015 9:42:22 PM

Friday, January 02, 2015 9:42:22 PM

Post# of 429483
40 days----

------FDA's actions "appeared to have ignored the SPA agreement, the deliberately high Congressional mandated rescission criteria and the agency's own guidance, including the requirement that the rescission basis rise to the level of a public health concern," said Healy. He said the FDA seems to have based its decision to rescind the SPA agreement on "underpowered, post-hoc, and exploratory analyses of data from different drug classes tested in different patient populations that was known to the FDA years before the SPA agreement was rescinded."

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