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.
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Senate Committee on Health, Education, Labor, and Pensions’ (Committee’s) Request for Information on Improving and Protecting Access to Gene Therapies…
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Department of Health and Human Services’ (HHS’) proposed Notice of Benefit and Payment Parameters (NBPP) for 2025.
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Centers for Medicare & Medicaid Services’ Draft CY 2025 Part D Redesign Program Instructions.
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.