Home
Search

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
BIO Letter to Congressional Leadership on the…
One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…
Learn more
John F. Crowley's One-Year Anniversary Letter to…
Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
Learn more
BIO Comments on Office of Management and Budget …
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
Learn more
All Letters, Testimony & Comments
  • Show All
Search
Results
BIO Submits Comments Re: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs
July 16, 2018
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 Submits Comments Re: Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule
July 16, 2018
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…
BIO's Comments on Proposed PTO Rules Change to Post-Grant Reviews
July 11, 2018
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…
BIO Recommendations for Tax Reform 2.0 Package
July 9, 2018
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…
BIO Comments on USDA-AMS National Bioengineered Food Disclosure Standard
July 3, 2018
RE: Proposed Rule- National Bioengineered Food Disclosure Standard- Doc. No. AMS-TM-17-0050 83; Fed. Reg. 19860 (May 4, 2018)
BIO Comments on FDA Draft Guidance on Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals
June 25, 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…
BIO Comments on FDA Draft Guidance on Scientific and Ethical Considerations for Including Pregnant Women in Clinical Trials
June 8, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry. This guidance is an important step towards providing…
BIO Comments on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation
June 8, 2018
BIO submitted comments to the Food and Drug Administration’s (FDA) on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation, following the Public Workshop on May 9, 2018. While advances in genomics and…
Biofuel and Agriculture Groups Petition EPA Re: Lost RFS Volumes from Small Refinery Exemptions
June 4, 2018
RE: Petition for Reconsideration of 40 C.F.R. §80.1405(c), EPA Docket No. EPA–HQ–OAR–2005–0161, promulgated in 75 Fed. Reg. 14,670 (Mar. 26, 2010); Petition for Reconsideration of Periodic Reviews for the Renewable Fuel Standard Program, 82 Fed. Reg…
Benefit-Risk: BIO Comments on Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan
May 31, 2018
May 31, 2018 Re: Docket No. FDA-2018-N-1010: Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan.Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug…