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ICH: BIO Submits Comments on FDA Draft Guidance ICH M10 Bioanalytical Method Validation

September 25, 2019

September 25, 2019

Re: FDA-2019-D-1469: M10 Bioanalytical Method Validation; International Council for Harmonisation; Draft Guidance for Industry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Drug Administration (FDA) for the opportunity to submit comments on the International Council for Harmonisation (ICH) Draft Guidance for Industry “M10 Bioanalytical Method Validation” (Draft Guidance or Guidance).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 believes that the scope of the Guidance is too broad and can be edited for specificity and clarity; please see our detailed line edits for lines 102-111 for our specific suggestion. Additionally, we note the Guidance covers method development for method validation. This raises significant concerns regarding expectations from different regions. We recommend re-wording for clarification or limiting the method development scope to changes to a validated method. Further, BIO believes that if this Guidance also applies to life cycle maintenance of products, the text should be updated to explicitly reference this, see specific comments throughout the accompanying chart.

BIO has a few suggestions regarding use of terminology throughout the Guidance. First, BIO suggests avoiding the term “pivotal” throughout the document, which may cause confusion if understood differently across ICH membership or regions. We have noted specific line numbers of its usage in the following chart. Second, BIO suggests that throughout the Guidance either the term “dilution ratio” or “dilution factor” be used consistently, rather than interchangeably.

Finally, a section discussing criteria to be applied for hybrid assays would be helpful.

BIO appreciates this opportunity to submit comments on “M10 Bioanalytical Method Validation”. We provide additional specific, detailed comments to improve the clarity of the Draft Guidance in the following chart. We would be pleased to provide further input or clarification of our comments, as needed.

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