BIO Comments on FDA's Revised Draft Guidance on Submission of Quality Metrics Data
March 27, 2017
BIO submitted comments on the Food and Drug Administration’s draft guidance, Submission of Quality Metrics Data.
BIO says it’s clear FDA has seriously considered the feedback on the 2015 Draft Guidance for Industry Request for Quality Metrics. In addition, BIO remains supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements. BIO provides additional suggestions on implementation, assessment, confidentiality of data, reporting for certain covered establishments, quality metrics, and more.
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2017-3-27 BIO Comments On Revised Quality Metrics FINAL
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
BIO submitted comments on the Food and Drug Administration’s draft guidance, Submission of Quality Metrics Data.
BIO says it’s clear FDA has seriously considered the feedback on the 2015 Draft Guidance for Industry Request for Quality Metrics. In addition, BIO remains supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements. BIO provides additional suggestions on implementation, assessment, confidentiality of data, reporting for certain covered establishments, quality metrics, and more.