FDA efforts to promote innovations in drug manufacturing that can improve quality and lower drug costs include a draft guidance describing a proposed CDER program under which stakeholders and its staff will have the opportunity to propose pharmaceutical quality standards for potential recognition by the agency. CDER would then maintain a “comprehensive” listing of these informally-recognized voluntary consensus standards. [See story on pp. 16-66 for more on current biopharmaceutical quality standard-setting efforts.]
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