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Combo Products: BIO Comments on Topics That May be Considered by the Food and Drug Administration Combination Product Policy Council

Re: Docket No. FDA–2017-N-0086: Suggestions, Recommendations and Comments for Topics That May be Considered by the Food and Drug Administration Combination Product Policy Council
 
Dear Sir/Madam:
 
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding FDA’s request for “Suggestions, Recommendations and Comments for Topics That May be Considered by the Food and Drug Administration Combination Product Policy Council.”
 
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.
 
We are generally supportive of the criteria listed to determine what topics the Council will consider. In addition to those criteria, we request that the Council develop recommendations for implementation of provisions introduced in the 21st Century Cures Act. In particular, recommendations to account for prior findings of safety and effectiveness or substantial equivalence for an approved constituent part, such as using a platform technology (e.g., same device constituent part approved with one drug used with a new drug) will be helpful. We also request more information about how the Council will address product specific inter-Center disagreements during a product’s review cycle as Sponsor requests for input must come through the Office of Combination Products. Additionally, we request that the Agency provide a common lexicon to be used across Centers.
 

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