Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments
More than 135 Emerging Biotech Leaders Urge…

We represent the community of emerging biotechnology companies whose researchers and scientists strive daily to develop innovative life-changing therapies and cures for patients. We take pride that we are providing hope to patients and their families and changing the world through medical breakthroughs

BIO Comments on CMS National Coverage Decision…

BIO provided comments on the Centers for CMS’ National Coverage Determination for Diagnostic Laboratory Tests using NGS for Medicare Beneficiaries with Germline (Inherited) Cancer.

BIO Comments on RFS Standards for 2020 and…
BIO's comments on the EPA’s administration of the of the Renewable Fuel Standard (RFS)  program and how it has put the investments made by BIO Member companies at risk and threatens to prevent growth in advanced and cellulosic biofuels as the…
All Letters, Testimony, & Comments
January 10, 2020
January 7, 2020 Re: Docket No. FDA–2019-N-3453: Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs Dear Sir/Madam: The Biotechnology Innovation Organization (BIO…
January 10, 2020
January 4, 2020 Re: Docket No. FDA–2019-N-5157: 2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program. Dear Sir/Madam: The Biotechnology Innovation Organization…
December 17, 2019
On December 16, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Food and Drug Administration’s (FDA’s) Notice to Public of Website Location of CDRH Fiscal Year 2020 Proposed Guidance Development; In Vitro…
December 17, 2019
On November 27, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Centers for Medicare and Medicaid Services’ (CMS’) National Coverage Determination for Diagnostic Laboratory Tests using Next Generation Sequencing (NGS)…
December 5, 2019
In a letter addressed to House Speaker Nancy Pelosi (D-CA) and House Republican Leader Kevin McCarthy (R-CA), 138 emerging biotech leaders warn that H.R. 3, the Lower Drug Cost Now Act, will “shatter the dreams” of patients and families who stand to…
August 30, 2019
BIO's comments on the EPA’s administration of the of the Renewable Fuel Standard (RFS)  program and how it has put the investments made by BIO Member companies at risk and threatens to prevent growth in advanced and cellulosic biofuels as the…
November 18, 2019
Biotechnology Innovation Organization (BIO) comments on the FDA docket, Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction. BIO also believes that risks associated with opioid…
November 13, 2019
The Biotechnology Innovation Organization provided comments to the Treasury Department and Internal Revenue Service on proposed regulations under Section 382 with respect to the built-in gain and built-in loss rules of Section 382(h).
November 11, 2019
In a recent letter, BIO applauded the Securities and Exchange Commission (SEC) for taking a proactive approach in amending its accelerated and large accelerated filer definitions. “If adopted as proposed, these amendments will benefit startups and…
October 30, 2019
In a recent letter, BIO’s Jim Greenwood commended Representative Steil (R-WI) for introducing the “Helping Startups Continue to Grow Act,” which extends the exemption afforded to Emerging Growth Companies under the JOBS Act from certain executive…