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Transparency Initiative:Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency’s Compliance and Enforcement Data

Dec 1 2011

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BIO Written Testimony: Spurring Job Growth Through Capital Formation While Protecting Investors

Dec 1 2011
On December 1, BIO submitted written testimony to the Senate Committee on Banking, Housing, and Urban Affairs on the importance of implementing policies that will spur job growth through capital formation while protecting investors.  

Risk-Based Monitoring: BIO Comments on Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

Nov 27 2011

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Potential NCD Topics: BIO's Comments

Nov 23 2011

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BIO Statement to the Presidential Commission for the Study of Bioethical Issues: Principles Regarding Ethical Performance of International Clinical Trials

Nov 16 2011
Recent reports have raised concerns about how clinical trials are being performed in other countries, particularly in the developing world...

China Patent Enforcement Comments to USPTO

Nov 10 2011
The importance of intellectual property protection is now understood in China.  However, it appears as though the IP laws are implemented and enforced in ways that benefit Chinese companies over foreign companies.  If China aims to be a leader in biotechnology it needs to understand that intellectual property protections are fundamental for creating an enabling environment for biotechnology.  In this regard, China has yet far to go.

Comments of Biotechnology Industry Organization on Economic Analysis to Implement the Clean Fuel Standard

Oct 31 2011
Comments of Biotechnology Industry Organization on the Clean Air Association of the Northeast States (“NESCAUM”) Economic Analysis of a Program to Promote Clean Transportation Fuels in the Northeast/Mid-Atlantic Region.

Comments of Biotechnology Industry Organization on Economic Analysis to Implement the Clean Fuel Standard

Oct 31 2011
Comments of Biotechnology Industry Organization on the Clean Air Association of the Northeast States (“NESCAUM”) Economic Analysis of a Program to Promote Clean Transportation Fuels in the Northeast/Mid-Atlantic Region.

International IP and Small Businesses: Novavax CEO Testifies on BIO's Behalf

Oct 27 2011
Stanley C. Erck, President and CEO of Novavax testified at the USPTO on behalf of BIO to discuss the importance of IP protection internationally for small biotechnology companies.

Human Subject Research Protections: BIO Comments on HHS ANPRM on Human Subjects Research Protections (Common Rule)

Oct 26 2011

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