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Orphan Drugs: BIO Comments on FDA Draft Guidance Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

Re: Docket No. FDA-2017-D-6380: Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

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PFDD: BIO Comments on FDA Public Workshop on Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input

Re: Docket No. FDA–2017-N-5896: Public Workshop: Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input

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BIO Comments on FDA Draft Guidance Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

Re: Docket ID: FDA-2017-D-6617: Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

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RMAT: BIO Submits Comments on FDA Draft Guidance Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

Re: Docket No. FDA-2017-D-6159: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

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Biofuel Advocates' Letter to EPA Administrator Pruitt on 2019 Cellulosic Volumes

As the U.S. EPA begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), a group of trade association advocates encourage the agency to take a renewed look at commercially ready cellulosic biofuels.

BIO Statement on President’s Proposed 2019 Budget

Washington, D.C. (February 13, 2018) — Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement in response to President Trump’s FY 2019 budget proposal.

BIO Expresses Strong Support for TRID Improvement Act

Legislation provides critical regulatory relief to small, pre-revenue emerging companies Washington, D.C. (February 12, 2018)— The Biotechnology Innovation Organization (BIO) announced its strong support today for H.R. 3978, the TRID Improvement Act. The bill includes a provision known as the Fostering Innovation Act, which offers much needed regulatory relief to small biotechnology firms. 

BIO Releases Report on State of Innovation for Pain and Addiction Therapeutics

Report highlights the need to stimulate innovation to battle the opioid epidemic Washington, DC (February 12, 2018) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases: Pain and Addiction Therapeutics. While many promising treatment approaches are in development, lower investment and pipeline breadth in pain and addiction relative to other disease areas with high societal health burdens demonstrates the need for incentivizing more research and clinical development in these areas.

BIO Food and Agriculture Section Comments to FDA on Guidance on Consultation Procedures: Foods Derived from New Plant Varieties

February 9, 2017 The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register1 regarding information collection burdens associated with its “Guidance on Consultation Procedures: Foods Derived from New Plant Varieties.”

BIO Applauds Introduction of the Vaccine Access Improvement Act

Washington, DC (February 9, 2018) – – The Biotechnology Innovation Organization (BIO) applauds Reps. Mike Kelly (R-PA) and Brian Higgins (D-NY) for introducing H.R. 4993, the Vaccine Access Improvement Act, which would promote timely access to new first-in-class childhood and maternal vaccines. The legislation would update the tax code to ensure new first-in-class vaccines are promptly covered under the National Vaccine Injury Compensation Program (VICP).