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BIO Comments on Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration

December 7, 2017
 
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
 
Re: Docket No. FDA-2017-N-5093: Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration
 
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.
 
BIO is committed to promoting a regulatory environment that continues to support and incentivize the biopharmaceutical ecosystem. Minimizing the regulatory burden on this critical sector of the American economy 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 in need.
 
To this end, BIO has 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.
 
Our priority recommendations for regulatory reforms fall into three categories:
  1. Accelerating Products to Market & Reducing Pre-Market Regulatory Costs
  2. Lowering Post-Market Regulatory Compliance Costs
  3. Removing Regulatory Barriers that Impede Value-Based Arrangements
We stand ready to work with the Agency to secure adoption and implementation of these reforms as quickly as practicable.

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