Home » Advocacy » Letters, Testimony & Comments

Letters, Testimony & Comments

FDA, Rare Diseases, Orphan Drug Act: Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases
May 31, 2010
Re: FDA–2010– N–0218: Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases; Public Hearing Dear Sir/Madam: The Biotechnology Industry Organization (BIO)...
Clinical Trials: BIO Comments to FDA on Draft Guidance on Non-Inferiority Clinical Trials
May 27, 2010
BIO proposes that the guidance make it more clear which methods are being proposed, as early as possible and consistently throughout the document. We also ask that the document provide additional guidance for the situation where the study has both...
Clinical Trials: BIO Submits Comments on the Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics
May 27, 2010
Re: FDA–2010–D–0090: Adaptive Design Clinical Trials for Drugs and Biologics Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on...
Bayh-Dole: Access to Early Capital Paper
May 27, 2010
Access to Early Capital In the United States and globally, commercial development of biotechnology relies on the continuing availability of capital to translate basic research into innovative products such as cures and therapies, seeds, foods,...
Technology Transfer: BIO Comments to Office of Science and Technology Policy on Commercialization of University Research
May 25, 2010
The Biotechnology industry Organization appreciates the opportunity to respond to the Request for Information issued by the Office of Science and Technology Policy and the National Economic Council on Commercialization of University Research.
FDA: Proposed Rule: Reporting Information Regarding Falsification of Data
May 20, 2010
BIO supports FDA’s stated goals of protecting the rights, safety and welfare of research subjects and of assuring the validity of data that the Agency receives in support of product approvals and for other purposes. BIO has concerns, however...
GREEN JOBS: Act Would Extend Cellulosic Biofuel Tax Credits, Make Algae Eligible
May 17, 2010
BIO and 34 companies and trade organizations sent a letter to Chairman Levin and Ranking Member Camp, of the House Ways and Means Committee supporting the Grow a Renewable Energy Economy Now - Jumpstart Other Biofuels Act of 2010 (GREEN JOBS), H.R...
Medicare: Comments on the Medicare Coverage Gap Discount Program Beginning in 2011
May 14, 2010
BIO supports the coverage gap discount program and believes that it will increase patient access to life-saving and life enhancing therapies.
Jim Greenwood's Address at the 2010 BIO International Convention
May 5, 2010
Options for Increasing Access to Medicines in the Developing World
May 1, 2010
In response to requests from its members, BIO has developed a formal BIO Policy Statement on Options for Increasing Access to Medicines in the Developing World to help educate BIO's members on the concrete and practical steps they can take to...
Pesticide Labeling: BIO Opposes EPA Wording of PPVR Label
April 30, 2010
Cloning: Letter to USTR from BIO, AMI, NCBA, NMA and NPPC
April 23, 2010
Letter urging countries to treat progeny of clones entering the food supply in both foreign and domestic markets as equivalent to conventionally raised animals.
Plant Biotechnology: Food Derived From New Plant Varieties
April 19, 2010
BIO’s April 19, 2010 comments to FDA RE: "Consultation Procedures: Foods Derived From New Plant Varieties" 75 Fed. Reg. 7274.
BIO’s comments to the EPA regarding proposed language on labeling for the Coat Protein Gene of Plum Pox Virus point out that directions for use in organic agriculture do not fall under FIFRA regulation.
April 15, 2010
BIO urges that any comprehensive climate change legislation include appropriate incentives for biotechnology solutions that produce clean and sustainable fuels and products, enhance industrial energy efficiency, and protect and enhance soil carbon.
Food and Drug Administration: BIO Comments on FDA Transparency Initiative
April 12, 2010
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.
Reauthorization of the Prescription Drug User Fee Act (PDUFA)
April 12, 2010
On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment in support of the reauthorization of the Prescription Drug User Fee Act and discuss how we can ensure achievement of the goals envisioned under PDUFA...
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.
April 9, 2010
Comments are regarding conservation and stewardship requirements, matching payments, establishment costs and annual payments, disclosure of competitively sensitive information, invasiveness determination and review, consistency with existing FSA...
BIO Letters of Support for Funding for the Cures Acceleration Network (CAN)
April 7, 2010
Letters expressing support for $500 million in funding for CAN for FY2011.
Draft Guidance on Assessment of Abuse Potential of Drugs
March 29, 2010
BIO comments to the Office of Management and Budget regarding "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering"
March 23, 2010
BIO writes the Office of Management and Budget (OMB) in the Office of the President supporting the existing United States Department of Agriculture (USDA) regulations regarding genetically engineered plants and animals.