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Intellectual Property: Compulsory Licenses Published by the Department of Industrial Policy and Promotion within India's Ministry of Commerce and Industry

Sep 29 2010
BIO is disappointed to see the recent DIPP’s discussion paper on compulsory licensing of biopharmaceuticals, which sends a deeply troubling message to investors and collaborators at a time when the industry and the Government of India are seeking to increase investment, collaboration, and innovation in the biotech sector.

FDA: Chemistry, Manufacturing, and Controls (CMC) Reporting

Sep 23 2010
BIO welcomes FDA’s initiative to apply scientific and risk based principles to reclassify changes as annually reportable. BIO encourages the Agency to consolidate existing Chemistry, Manufacturing, and Controls (CMC) reporting guidance, clarify how CMC reporting for biologics will be addressed under future guidance, and help reduce the potential for unintended consequences that may inadvertently increase the regulatory reporting burden.

Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals

Sep 23 2010
Comments on the Department of Defense’s proposed rule to implement Section 703 of the National Defense Authorization Act for Fiscal Year 2008.

DOE: Loan Guarantee Program for Advanced Biofuels, Renewable Chemicals

Sep 20 2010
BIO’s letter to President Obama proposes several necessary steps to fix the LGP and achieve the goal of near-term commercialization of advanced biofuels, biochemicals, and bioproducts

Genetically Engineered Salmon: FDA, VMAC Advisory Committee Meeting

Sep 20 2010
BIO’s Dr. David Edwards explains that the process of bringing this application through the regulatory system is based upon the rigorous process at the U.S. Food and Drug Administration (FDA) for approval of a new animal drug, which BIO supports as the most effective way to determine both the safety and efficacy of the recombinant DNA construct in the target animal and the safety of the food harvested from the animal for human consumption and enjoyment.

HHS: Interim Final Rules for Health Plans as They Relate to Vaccine Coverage Under the Patient Protection and Affordable Care Act

Sep 17 2010
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Department of Health and Human Services’ interim rules for group health plans related to coverage of preventive services under the Patient Protection and Affordable Care Act (ACA).

FDA: Investigational New Drug Applications; Co-Development of Investigational New Drugs

Sep 7 2010

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Centers for Medicare and Medicaid Services (CMS): Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2011 Payment Rates

Aug 31 2010

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Centers for Medicare and Medicaid Services (CMS): Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2011 Payment Rates

Aug 31 2010

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Biodefense: Public Health Security and Bioterrorism Preparedness and Response Act, Review and Republication of Toxin List

Aug 30 2010

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