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Risk Evaluation: BIO Comments on ICH's Proposed Guideline on E2C(R2) Periodic Benefit-Risk Evaluation Report

May 10 2012

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BIO's Suppport for the Reauthorization of the Prescription Drug User Fee Act (PDUFA V)

May 10 2012

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Drug Safety: BIO Comments on FDA's Communication to the Public

May 7 2012

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Drug Safety: BIO Comments on FDA's Draft Guidance on Classifying Significant Postmarket Drug Safety Issues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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (February 2012) (“Q&A Draft Guidance”).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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”(the Draft Guidance).