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Quality Metrics: BIO Comments on FDA Revised Draft Guidance "Submission of Quality Metrics Data"

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s Revised Draft Guidance for Industry Submission of Quality Metrics Data (Revised Draft Guidance).

Re: Docket No. FDA-2015-D-2537: Submission of Quality Metrics Data; Revised Draft Guidance for Industry

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s Revised Draft Guidance for Industry Submission of Quality Metrics Data (Revised Draft Guidance).

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

BIO thanks the FDA for revising and publishing for public stakeholder input a Revised Draft Guidance regarding quality metrics. It is clear from this revised document that FDA has seriously considered the feedback on the initial 2015 Draft Guidance for Industry Request for Quality Metrics.[1]  We appreciate the inclusion in the Revised Draft Guidance of Appendix B: Examples to provide companies additional guidance regarding each of the metrics FDA will be calculating.

We would like to reiterate that in general, BIO is supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements. We believe metrics, when contextualized, tested, and appropriately defined, have the potential to provide a valuable tool to quantify product quality. However, we reiterate that any metrics collection must have the appropriate benefit/burden balance for both the Agency and industry.

It is important to ensure that the terminology used is well-defined and as specific as possible. The effort taken to prepare these metrics should be commensurate with the value they provide in establishing or predicting the quality status of a manufacturing site or product. We believe that open dialogue between FDA and industry will be a key factor in the success of this program. BIO members are committed to manufacturing high-quality products for patients and fully support the underlying goals of this program. We offer the below suggestions to ensure the success of this initiative for all stakeholders.

 

[1] BIO Comments on FDA Draft Guidance Request for Quality Metrics (November 2015) https://www.bio.org/advocacy/letters/quality-metrics-bio-comments-fda-draft-guidance-request-quality-metrics

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