BIO Comments on Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration
December 7, 2017
BIO submitted comments on Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration (FDA).
BIO is committed to promoting a regulatory environment that continues to support and incentivize the biopharmaceutical ecosystem. Minimizing the regulatory burden on the biopharmaceutical sector will foster small business growth, create good, high-paying jobs, directly and indirectly expand the economy, and expedite the development and delivery of safe and effective therapies to patients.
BIO developed a priority list of regulations and guidance documents that, if modified or eliminated, would significantly decrease regulatory costs, advance the fast and safe development and delivery of effective therapies, and drive investment in innovation by fostering an environment that recognizes the value these new medicines bring to patients and the overall healthcare system. These documents fall into three categories: Accelerating Products to Market & Reducing Pre-Market Regulatory Costs, Lowering Post-Market Regulatory Compliance Costs, and Removing Regulatory Barriers that Impede Value-Based Arrangements.
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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 comments on Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration (FDA).
BIO is committed to promoting a regulatory environment that continues to support and incentivize the biopharmaceutical ecosystem. Minimizing the regulatory burden on the biopharmaceutical sector will foster small business growth, create good, high-paying jobs, directly and indirectly expand the economy, and expedite the development and delivery of safe and effective therapies to patients.
BIO developed a priority list of regulations and guidance documents that, if modified or eliminated, would significantly decrease regulatory costs, advance the fast and safe development and delivery of effective therapies, and drive investment in innovation by fostering an environment that recognizes the value these new medicines bring to patients and the overall healthcare system. These documents fall into three categories: Accelerating Products to Market & Reducing Pre-Market Regulatory Costs, Lowering Post-Market Regulatory Compliance Costs, and Removing Regulatory Barriers that Impede Value-Based Arrangements.