BIO Comments on FDA's Revised Draft Guidance on Submission of Quality Metrics Data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BIO submitted comments on the Food and Drug Administration’s draft guidance, Submission of Quality Metrics Data.
BIO says it’s clear FDA has seriously considered the feedback on the 2015 Draft Guidance for Industry Request for Quality Metrics.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
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.
BIO submitted comments on the Food and Drug Administration’s draft guidance, Submission of Quality Metrics Data.
BIO says it’s clear FDA has seriously considered the feedback on the 2015 Draft Guidance for Industry Request for Quality Metrics.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.