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BIO Comments on FDA Draft Guidance on ANDAs for Certain Highly Purified Synthetic Peptide Drug Products Referring to Listed Drugs of rDNA Origin

February 4, 2017

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.

BIO supports enhanced regulatory guidance on considerations for approval of generic and follow-on medicine products, as well as the FDA’s recognition of the appropriateness of the 505(b)(2) application for regulatory assessment of generic medicines and follow-on peptide products.

However, BIO requests FDA provide greater scientific reasoning and specificity on its analysis for the sweeping determination that an ANDA submission may be appropriate for the five specific peptides referenced the guidance. BIO’s comments address this concern in more detail.

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BIO Letter ANDA For Synthetic Peptides 2-2-18
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