FDA Opioid Policy: Senate Takes A Speak Softly Approach
Senate Appropriations Committee says FDA should finalize draft abuse-deterrent opioids guidance, but unlike House, does not make funding contingent on completion.
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Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.
Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.
Agency officials can now discuss the ideas that have been accepted, though not in great detail.