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Is Draft Guidance More Than Meets The Eye? Senators Seek Answers From FDA

Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.

Four Republican senators are pressing FDA about charges from industry that the agency is using draft guidance documents to make substantive policy changes.

The lawmakers want information from FDA on guidelines that currently remain in the draft stage, the agency’s plans for finalizing those guidances, and FDA’s policies for ensuring that its staff...

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