On the recordMarch 11, 2015
That does not seem the way it should be. I would hope FDA would commit to complete the rulemaking...
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congress.govThat does not seem the way it should be. I would hope FDA would commit to complete the rulemaking...
Leahy criticizes the FDA's proposed rule for generic drug labeling and urges for timely updates.
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Congress was the original classification authority (OCA). It let that power essentially slip away to the Executive Branch.
I can say with absolute certainty that the proposed rules directly conflict with the legislation on a variety of matters, especially on provisions that limit access to the PTAB.