BIO Comments on Food and Drug Administration Combination Product Policy Council
April 13, 2017
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.
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
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.