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BIO submits comments to Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models

Dec 23 2016
The Biotechnology Innovation Organization appreciates the opportunity to offer comments to the final rule Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models.

BIO Comments on the National Quality Forum Health and Wellbeing 2015-2017 Report

Dec 23 2016
BIO appreciates the opportunity to comment on the National Quality Forum (NQF) Health and Wellbeing 2015-2017 report.

BIO Submits Comments on FDA Draft Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

Dec 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Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance entitled, “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) devices” 

BIO Urges the Senate to Pass the 21st Century Cures Act

Dec 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

Dec 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 parties with no legitimate interests in the patented technology

DSCSA: BIO Submits Comments to FDA's Public Meeting on Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act

Nov 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 ...

BIO Position on Proposals to Provide for Export Manufacturing Exemption during Patent Term Restoration

Nov 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

Nov 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 Biotechnology (Coordinated Framework) has made it possible for BIO members to develop products that have improved the productivity of plant and animal agriculture while decreasing their environmental impacts, enhanced food safety and quality, increased the use of renewable resources and decreased manufacturing costs and energy use.

October 2016 BIO Letter to Congress re Bioenergy Tax Credits

Oct 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 urges Congress to advance a multi-year extension of the Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, and the Alternative Fuel Vehicle Refueling Property.

Codevelopment: BIO Comments on FDA Draft Guidance Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product

Oct 13 2016

Re: Docket No. FDA-2016-D-1703

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