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Letter, Identification of Countries involving the Special 301 provisions

BIO Members have a particular interest in encouraging uniform and robust intellectual property protection in all countries and regions of the world. As a general matter, BIO notes with concern recent trends in a number of countries that undermine the intellectual property protection essential to provide an enabling environment for innovative biotech companies.

BIO comments on National Trade Estimate Report on Foreign Trade Barriers

This letter is submitted by the Biotechnology Industry Organization (BIO) in response to the request for public comment with respect to the annual National Trade Estimate Report on Foreign Trade Barriers in the Federal Register on September 24, 2009.

Comments, 8th Meeting of the Convention on Biological Diversity (CBD) Ad Hoc Open-ended Working Group on Access and Benefit-Sharing

Comments, 8th Meeting of the Convention on Biological Diversity (CBD) Ad Hoc Open-ended Working Group on Access and Benefit-Sharing.

Letter, United Nations Framework Convention on Climate Change

U.S. Department of State

The Draft Guidance for Industry on Good Importer Practices

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Good Importer Practices. This guidance provides a useful quality systems framework for importers across all FDA-regulated industries to promote the safety of imported products. Biotechnology companies are currently leading significant efforts to further enhance the safety and security of biopharmaceuticals at every step of the supply chain and we encourage the FDA to minimize the potential for divergence between this guidance and current drug and biologic Good Manufacturing Practices regulations.

Comments, Trans-Pacific Partnership Free Trade Agreements

Office of the U.S. Trade Representative

BIO Applauds Fifth Anniversary of the Biosafety Protocol

The Biosafety Protocol is an international environmental treaty under the United Nations Convention on Biological Diversity, which establishes rules and procedures for the international trade in certain agricultural biotechnology products. 

Comments on the Identification of Countries involving the Special 301 Provisions

The Biotechnology Industry Organization (BIO) is submitting this letter in response to the request by the United States Trade Representative (USTR) for comments involving the “Special 301” provisions of the Trade Act of 1974. BIO is very pleased to have the opportunity to submit these comments, and respectfully requests that USTR consider the following remarks.

Comments, WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG”)

BIO's comments on the Revised Draft of Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.

Biotechnology Industry Approves Product Launch Stewardship Policy

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