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Letters, Testimony & Comments

Medicaid: BIO Comments to Arizona on Specialty Pharmacy Drugs and Services Programs
November 10, 2009
Comments expressing concerns that the contract described in the RFP appears to be incompatible with the 340B program’s requirement that discounted drugs be dispensed only to patients of the entity receiving the discount, a requirement...
BIO's comments in response to the Arizona Health Care Cost Containment System (AHCCCS) Administration's Notice of Request for Proposal (RFP) on the Specialty Pharmacy Drugs and Services Program
November 10, 2009
Letter regarding BIO comments on Notice of Request for Extension of Approval of an Information Collection; Introduction of Organisms and Products Altered or Produced Through Genetic Engineering
November 9, 2009
Agriculture: Stop Work on Food Labeling, for Foods Derived from Biotechnology
November 9, 2009
Letter to Health Canada Regarding BIO Position on Labeling of Genetically Modified Food.
FDA: BIO Comments on FDA’s Transparency Task Force
November 6, 2009
Clear, consistent and open communication with the public and regulated industry, conducted in a manner that balances the importance of protecting competitive commercial information, is a critical FDA function and essential for protecting and...
Food and Drug Administration Transparency Task Force, Public Meeting
November 6, 2009
Jim Greenwood’s prepared remarks for BioInvest 2009 in Mumbai, India
November 5, 2009
Biotech Industry: Global Outlook and India’s Role in the Biotech World
BIO comments on National Trade Estimate Report on Foreign Trade Barriers
November 3, 2009
Dear Ms. Blue, 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...
Decision, ACLU v. Myriad/US Patent & Trademark Office
November 3, 2009
Comments, National Trade Estimate (NTE) Report on Foreign Trade Barriers and Reports on Sanitary and Phytosanitary and Standards-Related Foreign Trade Barriers
November 1, 2009
  Dear Ms. Blue: The Biotechnology Industry Organization (BIO) is submitting this letter in response to the request by the United States Trade Representative (USTR) for comments to compile the National Trade Estimate (NTE) Report on...
Economy: House Testimony on Increasing Access to Capital for Small Business
October 24, 2009
Hearing Testimony for House Small Business Committee by Martin Sabarski, CFO of HR BioPetroleum, Inc. Hearing Testimony before the House Small Business Committee
Increasing Access to Capital for Small Businesses
October 14, 2009
Good morning Chairwoman Velázquez, Ranking Member Graves, Members of the Committee, the Staff of the Committee, ladies and gentlemen. My name is Martin Sabarsky, and I am the Chief Financial Officer and Chief Operating Officer of HR...
BIO Comments to FDA on Post-marketing Studies and Clinical Trials
October 13, 2009
BIO requested additional clarification regarding the criteria for selecting post-market studies or trials, the timeframe for interacting with sponsors when selecting appropriate post-marketing commitments and post-marketing requirements, and the...
Incorporation of Physical-Chemical Identifiers (PC-ID) into Solid Oral Dosage Form Drug Products for Anticounterfeiting
October 13, 2009
Postmarketing Studies and Clinical Trials -- Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act
October 13, 2009
BIO Comments on Flaws in Report on Gene Patents and Patient Access to Genetic Tests
October 8, 2009
Recommendations in the Secretary’s Advisory Committee on Genetics, Health and Society draft report on Gene Patenting and Licensing and Their Impact on Patient Access to Genetic Tests would restrict the ability to obtain or undermine the...
BIO Statement on Draft Report on Gene Patents and Patient Access to Genetic Tests
October 8, 2009
Provisions in Climate Change legislation that Could Place Biofuels Under an Emissions Cap
October 1, 2009
Letter to Sen. Barbara Boxer, chairperson of the Senate Environment and Public Works about emissions caps for biofuels in climate change legislation.
International Biotechnology Climate Coalition Comments to UN Framework Convention on Climate Change
October 1, 2009
BIO and other members of the Coalition expressed concern that the language of the treaty on Long-term Cooperative Action (LCA) would result in disincentives to realizing the benefits of biotechnology and weaken intellectual property protection.
Biobased Products: Labeling for Biobased Products
September 29, 2009
Letter congratulating USDA in Implementing voluntary labeling for Biobased Products