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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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (February 2012) (“Q&A Draft Guidance”).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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”(the Draft Guidance).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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BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements

Mar 29 2012

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BIO Comments to FDA on Unsolicited Requests for Off-Label Information

Mar 26 2012
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Agency’s Draft Guidance for Industry on Responding to Unsolicited requests for Off-Label Information About Prescription Drugs and Medical Devices (Draft Guidance). This Draft Guidance, as well as FDA’s December 28, 2011 Notice; Request for Comments on Communications and Activities Related to Off-Label Uses[1]are important steps in developing policies on manufacturer communications involving off-label information. BIO is submitting separate comments to FDA addressing the Agency’s December 28, 2011 Notice and Request for Comments.  Further, BIO looks forward to additional opportunities to comment on other issues raised in the July 5, 2011 citizen petition submitted to FDA, including interactions with formulary committees, payors and similar entities, and dissemination of third-party clinical practice guidelines. [2]  

BIO Comments to FDA on Scientific Exchange related to Off-Label Information

Mar 26 2012
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or the Agency) for the opportunity to submit comments on this important topic.  The ability to exchange scientific information with healthcare practitioners and the public is absolutely essential to the activities of BIO members.  BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.  BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.  Given this fundamental reliance upon the flow of scientific information, our members believe it is critical for the Agency to reconsider its current approach to communications and activities related to both off-label uses of marketed drug products and uses of drug products not yet legally marketed.