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.
Dear Congressional Leaders:On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to…
Re: Docket No. CDC-2025-0783; Advisory Committee on Immunization Practices (ACIP) MeetingDear Dr. Zadeh and Members of the ACIP:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide comments to the Advisory Committee…
Chairman Cassidy, Ranking Member Sanders, and distinguished Members of the Committee:Thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO), which represents more than 1,000…
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.