Regulatory Update: Opportunity to Advance Pharma Quality
In March 2017, ISPE submitted an extensive and detailed response1 to the 2016 US Food and Drug Administration (FDA) draft guidance "Submission of Quality Metrics Data,"2 the associated Federal Register Notice,3 and webinar.4 These comments reflected ISPE's conclusion that the program, as proposed, has low or no value, and the burden on companies would be substantial.
- 1. International Society for Pharmaceutical Engineering. Response to FDA Docket Number FDA-2015-D-2537. 27 March 2017. https://ispe.org
- 2. US Food and Drug Administration. "Submission of Quality Metrics Data." Guidance for Industry. Draft Guidance. Revision 1. November 2016. www.fda.gov/downloads/drugs/guidance-complianceregulatoryinformation/guidances/ucm455957.pdf
- 3. Federal Register. "Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments." 25 November 2016. https://federalregister.gov/d/2016-28332
- 4. US Food and Drug Administration. CDER Small Business and Industry Assistance. "Revised Draft Guidance for Industry: Submission of Quality Metrics Data." Webinar. November 2016. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ SmallBusinessAssistance/ucm530313.htm