FDA Drug Quality Standards Plan Aims To Spur Development, Cut Costs

FDA released a draft guidance on Wednesday (Feb. 13) that calls for drug industry stakeholders and agency staff to draft a set of pharmaceutical quality consensus standards that potentially could be recognized by the agency. The program, according to FDA Commissioner Scott Gottlieb, could help expedite drug development, streamline drug reviews and lower drug costs. The agency hopes to spur development of standards for emerging technologies that have potential to improve drug quality and reduce drug manufacturing costs. While the...