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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…
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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…
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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…
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BIO Submits Comments on FDA Draft Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
December 23, 2016
Re: Docket No. FDA-2016-N-0001: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance entitled, “Coordinated Development of Antimicrobial Drugs and…
BIO Urges the Senate to Pass the 21st Century Cures Act
December 7, 2016
On behalf of the Biotechnology Innovation Organization (BIO), I am writing to offer our strong support H.R. 34, the 21st Century Cures Act, and urge the Senate to pass this important legislation.
New York U.S. Congressional Delegation Sends Letter to PTO Head Michelle Lee
December 7, 2016
Ten members the U.S. House of Representatives from New York wrote to U.S. Patent and Trademark Office Director Michelle K. Lee to express concern with continued abuse of the inter partes review (IPR) system by financial speculators and other third…
DSCSA: BIO Submits Comments to FDA's Public Meeting on Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act
November 23, 2016
Re: Docket No. FDA–2016–N–2673: Public Meeting on Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food…
BIO Position on Proposals to Provide for Export Manufacturing Exemption during Patent Term Restoration
November 18, 2016
Export manufacturing exemptions weaken the IP protections afforded by Supplementary Protection Certificate and Patent Term Restoration.
BIO Submits Comments in Reponse to the Notice of a Request for Information re Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology
November 2, 2016
BIO is pleased to submit these comments in response to the Notice of Request for Public Comment published by the National Science and Technology Council, Science and Technology Policy Office. The Coordinated Framework for Regulation of…
October 2016 BIO Letter to Congress re Bioenergy Tax Credits
October 18, 2016
BIO issued a letter to Congressional Leadership, the Senate Finance Committee Chairs, and the House Ways and Means Committee Chairs calling for the extension of renewable energy tax credits slated to expire at the end of 2016. In its letter, BIO…
Codevelopment: BIO Comments on FDA Draft Guidance Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
October 13, 2016
Re: Docket No. FDA-2016-D-1703Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Principles for Codevelopment of an In Vitro Companion…
Compounding: BIO Comments on FDA Draft Guidances on "Essentially Copies"
October 13, 2016
Re: Docket No. FDA-2016-D-1309: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; andFDA-2016-D-1267: Compounded…
Compounding: BIO Comments on FDA Draft Guidance nsanitary Conditions at Compounding Facilities
October 6, 2016
Re: Docket No. FDA–2016–D–2268: Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for…