Under the proposed Senate framework, FDA would be barred from requiring compounding manufacturers to submit NDAs and ANDAs pre-inspection and labeling requirements before these drugs reach patients.
Joe Pitts: “Under the proposed Senate framework, FDA would be barred from requiring compounding manufacturers to submit NDAs and…”
On the recordJuly 15, 2013
Source
congress.govEditor's note · Context
Pitts highlights concerns about FDA's regulatory limitations on compounding manufacturers.
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