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BIO Submits Comments on Nonclinical Assessment of Investigation Enzyme Replacement Therapies

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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the &ldquo;Draft Guidance for Industry on Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.&rdquo;</p>

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.”

BIO appreciates the release of this Draft Guidance and, overall, believes it to be well thought-out and written. It provides clarity and insights on FDA’s flexibility for Sponsors to optimize the design of efficient nonclinical programs to support the development of Enzyme Replacement Therapy products (ERTs).