USTR’s Annual Report on Sanitary and Phytosanitary (SPS)

Oct 4 2010
BIO encourages USTR and other U.S. government agencies to renew efforts to ensure that any SPS measures affecting exports of U.S. products derived from modern biotechnology be based on scientifically verifiable criteria and be consistent with the SPS Agreement.

Stewardship: Actions to be Taken Prior to Launching Special Traits

Oct 4 2010
BIO policy recommends that BIO members anticipate, consider and develop approaches to help manage and mitigate any potential significant, unintentional processing, product functional or compositional negative effects in crop use or processing streams.

Synthetic Biology: Proposals for Regulating Industry Uses of New Biotechnologies

Oct 1 2010
BIO submitted letters to the White House Office of Science and Technology Policy and the Presidential Commission for the Study of Bioethical Issues proposing formation of a federal interagency working group to coordinate all agencies’ approaches to regulating synthetic biology.

Pandemic Influenza: Vaccine production and additional planning for future possible pandemic influenza

Oct 1 2010
BIO recommends that countries and NGO’s be encouraged to allocate funds to broad educational programs directed to the public on the importance of both individual and community protection against seasonal influenza as a way to build stronger understanding of the role of vaccines in preventing influenza now and in the future.

IRS: Implementation of Biopharmaceuticals Manufacturers Fee

Sep 30 2010
BIO is hopeful that the IRS, Treasury and the specified government agencies will work closely with industry to ensure that the fee is implemented in as fair and transparent a manner as possible.

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.