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.
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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.