BIO Comments on FDA's Revised Draft Guidance on Submission of Quality Metrics Data
BIO submitted comments on the Food and Drug Administration’s draft guidance, Submission of Quality Metrics Data.
BIO says it’s clear FDA has seriously considered the feedback on the 2015 Draft Guidance for Industry Request for Quality Metrics.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.