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BIO's Comments on the Centers for Medicare & Medicaid Services' (CMS) Medicare Coverage Gap Discount Program Appeals Guidance

Apr 22 2011
BIO addressed the process and bases for appeals and the implementation of the final appeals guidance.

National Institutes of Health (NIH) Uses American Recovery and Reinvestment Act (ARRA) Funding to Advance Scientific Research

Apr 19 2011

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BIO Comments on the FDA's Draft Guidance for the Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies

Apr 19 2011
BIO recognizes the importance of appropriate consideration and use of clinical pharmacogenomic data by the FDA to ensure that this information is used appropriately to improve healthcare outcomes. BIO represents companies that are involved specifically with pharmacogenomics, therefore, welcome the opportunity to work with the FDA as the Agency develops guidance on clinical pharmacogenomic studies through all phases of product research and development.

FDA's Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets

Apr 18 2011
BIO supports the Agency's efforts to fully utilize new electronic health care data sources for post-approval pharmacoepidemiologic studies. These new data resources offer great promise to revolutionize the practice of pharmacovigilance with more timely and cost-effective methods for conducting post-market studies, but great care must be taken to minimize the potential for confounding and bias. We hope the Draft Guidance will provide additional transparency in scientific exchange between FDA and Sponsors when initiating appropriate pharmacoepidemiological studies in a regulatory context. With this goal in mind, we request clarification of several aspects of the Draft Guidance, particularly around the process for submitting and reviewing study protocols.

Taking Measure of Countermeasures: How Biotechnology Can Help Protect the United States

Apr 13 2011
In testimony given to the to the Committee on Homeland Security's Subcommittee on Emergency Preparedness, Response, and Communications, Phyllis Arthur reviews government and biotechnology industry efforts to protect the homeland through accelerated research, development, and acquisition of chemical, biological, radiological and nuclear medical countermeasures.

Renewable Fuel Standard: BIO Asks Congress to Maintain Commitment

Apr 13 2011
The Renewable Fuel Standard provides the market and regulatory certainty necessary to drive private investment and maintain progress in research and development of advanced biofuels, BIO said in written testimony submitted to the Senate Environment and Public Works Committee.

Testimony on Rhode Island Labeling Bill

Apr 13 2011
The Rhode Island state legislature is considering a bill (House Bill 5629) requiring mandatory labeling of foods produced with agricultural biotechnology or foods that contain biotech ingredients. BIO submitted testimony opposing the measure to the House Committee on Health, Education and Welfare, saying that food labeling requirements should be science-based to give consumers meaningful information about the foods they buy and eat.

Clean Energy: Biomass Should Qualify for Standard

Apr 11 2011
In comments to the Senate Energy and Natural Resources Committee's "Clean Energy Standard White Paper", BIO argues that biomass should qualify for renewable energy credits.

BIO Comments on FDA's Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability

Apr 7 2011
BIO supports the ongoing integration of electronic health records (EHR) into the healthcare delivery system and industry adoption of electronic data capture (EDC) systems, and we are hopeful that these systems will introduce new capabilities and efficiencies into the clinical trial enterprise. BIO members welcome technological advances that will assist them in conducting clinical investigations in a more efficient manner. In fact, smaller emerging companies not burdened by legacy systems and practices may have greater flexibility and willingness to adopt new EDC systems. However, while BIO appreciates the principles outlined in the Draft Guidance, many of the responsibilities placed on the investigator remain ambiguous, and may create more potential burdens and uncertainty than clarification for biotech companies involved in clinical investigations.

Biotech Leader Provides Testimony at Congressional Hearing on SBIR/STTR Renewal

Apr 7 2011
The House Subcommittee on Healthcare and Technology held a hearing on The Creating Jobs Through Small Business Innovation Act of 2011, a bill that would reauthorize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which help fund small innovative companies on the brink of new technologies and discoveries.