Letters, Testimony & Comments

Re: Docket No. FDA-2018-D-2032: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance, “Limited Population Pathway for Antibacterial and Antifungal Drugs …

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials. The draft guidance is an important step towards ensuring stakeholders…

As the U.S. Environmental Protection Agency (EPA) begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), we encourage the agency to take a renewed look at commercial-ready cellulosic biofuels.

BIO sent the following letter to Representative Barbara Comstock following her introduction of H.R. 6390, the “Study of Underrepresented Classes Chasing Engineering and Science Success Act of 2018” or the SUCCESS Act  

First and foremost, this is an extraordinary time for biotechnology. The therapies in development and coming to the market are unlike any we have seen in the history of medicine. We have entered into a new era of medicine, and BIO members are making…

BIO’s comments on the Proposed Rule are focused on the following areas:  Proposed changes to the IPPS for coverage and payment of Chimeric Antigen Receptor T-cell (CAR T) Therapy and other Transformative Therapies;  Updates to the Medicare…

Comments of BIO on the United States Patent and Trademark Office’s proposed revisions to the standard for construing disputed claim terms in inter partes reviews, post-grant reviews, and covered business method reviews (“post-grant…

As the Ways and Means Committee begins to develop new tax legislation, it is imperative that they include policies to incentivize, or at a minimum remove obstacles that impede, the emerging biotechnology companies that are conducting life-changing…

RE: Proposed Rule- National Bioengineered Food Disclosure Standard- Doc. No. AMS-TM-17-0050 83; Fed. Reg. 19860 (May 4, 2018)

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals. The draft guidance is a positive step toward…