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Drug Safety: BIO Comments on FDA's Draft Guidance on Classifying Significant Postmarket Drug Safety Issues

May 7 2012

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BIO Endorsement Letter for the Senate Health, Education, Labor and Pensions Committee Markup of the Food and Drug Administration Safety and Innovation Act (FDASIA)

May 2 2012

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International Patent Issues Highlighted at House Judiciary Committee Hearing: BIO Submits Biotech's Challenges

Apr 25 2012

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BIO's Testimony to the April 18, 2012 House Committee on Energy and Commerce, Subcommittee on Health Hearing on "FDA User Fees 2012: How Innovation Helps Patients and Jobs"

Apr 18 2012

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Biosimilars: BIO Comments on Questions and Answers Regarding Implementation of BPCIA

Apr 16 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (February 2012) (“Q&A Draft Guidance”).   

Biosimilars: BIO Comments on Quality Considerations

Apr 16 2012

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Biosimilars: BIO Comments on Scientific Considerations

Apr 16 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”(the Draft Guidance).

CED: BIO's Comments to the the Medicare Evidence Development & Coverage Advisory Committee’s (MEDCAC) questions regarding the evidentiary characteristics of coverage with evidence development (CED)

Apr 15 2012

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Agriculture Energy Coalition Letter to House and Senate Agriculture Committees

Apr 6 2012
More than 100 organizations representing a broad and diverse array of renewable energy, energy efficiency, farm, ranch, commodity, environmental, and other groups sent a letter to the leaders of the House and Senate Agriculture Committees asking for reauthorization and funding of Farm Bill energy title programs .

2012 AMP Proposed Rule: BIO's Comments on the Centers for Medicare and Medicaid Services’ Proposed Rule regarding covered outpatient drugs under the Medicaid Program

Apr 1 2012

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