FDA efforts to promote innovations in drug manufacturing that can improve quality and lower drug costs include a draft guidance describing a proposed CDER program under which stakeholders and its staff will have the opportunity to propose pharmaceutical quality standards for potential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.]
[/membership][membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]