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BIO Submits Comments on FDA Draft Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance entitled, “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) devices” 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

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

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

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

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

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

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

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

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Compounding: BIO Comments on FDA Draft Guidances on "Essentially Copies"

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;...

Compounding: BIO Comments on FDA Draft Guidance nsanitary Conditions at Compounding Facilities

Re: Docket No. FDA–2016–D–2268: Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability ...