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Biologics: EMA Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substance: Non-clinical and Clinical Issues

Dec 30 2011

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Drug Shortages: BIO Comments on Center for Drug Evaluation and Research (CDER), Approach to Addressing Drug Shortage; Public Workshop; Request for Comments

Dec 22 2011

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Biosimilar User Fees: BIO Testifies at Biosimilar User Fee Public Hearing

Dec 15 2011

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Glyphosate Tolerant H7-1 Sugar Beets Request: Environmental Impact

Dec 12 2011
BIO comments in response to the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS or the Agency) Draft Environmental Impact Statement-October 2011, Glyphosate Tolerant H7-1 Sugar Beets Request for Nonregulated Status.

China Compulsory License Proposed Provisions Draw Reaction from BIO

Dec 8 2011
BIO's members appreciate the recognition by the Chinese government that robust patent protections will incentivize an innovative biotechnology sector in China.  However, this can only be achieved with policies that ensure rare and narrow use of compulsory licenses only in extreme circumstances.

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Risk-Based Monitoring: BIO Comments on Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring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