BIO Comments on Food and Drug Administration Combination Product Policy Council
BIO submitted comments to the Food and Drug Administration (FDA) on topics that may be considered by the Food and Drug Administration Combination Product Policy Council.
BIO is generally supportive of the criteria listed to determine what topics the Council will consider. In addition to those criteria, BIO requests the Council develop recommendations for implementation of provisions introduced in the 21st Century Cures Act. BIO also requests more information about how the Council will address product-specific inter-Center disagreements during a product’s review cycle, as well as a common lexicon to be used across Centers.