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BIO Comments to the EPA RVOs Docket ID No EPA-HQ-OAR-2013-0479

May 8 2015
The Biotechnology Industry Organization (“BIO”) is pleased to have the opportunity today to comment on the U.S. Environmental Protection Agency’s (“EPA”) Proposed Rule on the 2014 Standards for the Renewable Fuel Standard (RFS) PrograM (“the proposed rule”) and the renewable volume obligations (RVO) for biofuels in 2014.

Shane Kovacs Executive Vice President & Chief Financial Officer, PTC Therapeutics, Inc.

Apr 30 2015
On behalf of the Biotechnology Industry Organization Before the United States House of Representatives Committee on Financial Services, Subcommittee on Capital Markets and Government Sponsored Enterprises --- Legislative Proposals to Enhance Capital Formation and Reduce Regulatory Burdens

Coalition for Safe and Affordable Food's Letter to House of Representatives re H.R. 1599, the Safe and Accurate Food Labeling Act

Apr 29 2015
We are writing on behalf of the Coalition for Safe and Affordable Food about a significant development that could impact American consumers, businesses, farmers and food manufacturers. At a time when legislative consensus is hard to come by, it is notable that substantial bipartisan support is building behind a national, voluntary food labeling standard for products containing ingredients derived from genetically modified organisms (GMOs).

U.S. Biotech Crops Alliance's Letter to European Commission Re Regulatory Procedure for Importing Biotech Products

Apr 28 2015
Dear Commissioner Andriukaitis, On March 12, 2015 the undersigned organizations, representing a broad section of the U.S. food and agricultural industry, provided comments on the review of the European Union's (EU) regulatory procedure for approving the import of new biotechnology products being conducted by DG SANTE. In our letter we stated that a number of core principles and commitments must result from this review (see attachment).

BIO Submits Comments to FDA on Pediatrics Stakeholders Meeting

Apr 23 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to present our views on pediatric drug development at the March 25 pediatric stakeholder meeting and to submit written comments to the docket. BIO applauds the leadership of the FDA for convening the stakeholder meeting to help foster collaboration and coordination across all pediatrics stakeholders, including industry, academia, the patient advocacy community, and government, so that we can work together to develop safe and effective new therapies for children.

BIO Files Amicus Brief in Amgen v. Sandoz

Apr 23 2015
BIO has filed a friend of the court brief at the Federal Circuit in the Amgen v. Sandoz case.

BIO Submits Comments to FDA on Next Generation Sequencing

Apr 20 2015

Letter to House Committee on Judiciary Chairmen Grassley and Goodlatte and Ranking Members Leahy and Conyers re Innovation Act

Apr 14 2015
Dear Chairmen Grassley and Goodlatte and Ranking Members Leahy and Conyers, We write as leading agricultural companies and producer organizations to urge caution as the Congress considers changes to the U.S. patent system. There is a concern that the Innovation Act, as currently drafted, will discourage investment in modern agricultural tools important to rural America by making patent rights more difficult to enforce and more challenging for companies and universities to cross-license agricultural technologies.

BIO Submits Comments on ClinicalTrials.gov Expansion

Mar 22 2015
The Biotechnology Industry Organization (BIO) thanks the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) for the opportunity to submit comments on the Notice of Proposed Rulemaking (NPRM) entitled Clinical Trials Registration and Results Submission.

BIO Testimony Regarding Hawaii SB 717: “AN ACT TO REPEAL THE REQUIREMENT THAT GASOLINE FOR MOTOR VEHICLES IN THE STATE INCLUDE 10% ETHANOL”

Mar 16 2015
Chairman Lee, Vice Chairman Lowen, and Members of the Committee, the Biotechnology Industry Organization (“BIO”) appreciates this opportunity to provide comments on SB 717, legislation repealing the requirement that gasoline for motor vehicles in the state include 10% ethanol. This proposal is of significant concern to BIO and its members in the State of Hawaii and throughout the country.