Letters, Testimony & Comments

July 31, 2014
 The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “The Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities.” BIO...
July 28, 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA, the Agency) for the opportunity to submit comments on the Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs....
July 14, 2014
The Honorable Lee Terry Chairman Energy & Commerce Subcommittee on Commerce, Manufacturing, and Trade United States House of Representatives Washington, D.C. 20510           ...
July 9, 2014
Biotechnology Industry Organization (“BIO”) is the world’s largest trade association, representing over 1100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United...
June 18, 2014
The Biotechnology Industry Organization (“BIO”) is the country’s largest biotechnology trade association, representing over 1100 companies, academic institutions, and biotechnology centers in all 50 states and in countries around...
June 12, 2014
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug...
June 11, 2014
  June 10, 2014   Jacob J. Lew Secretary, Department of the Treasury 1500 Pennsylvania Avenue, NW Washington, D.C. 20220                 ...
June 9, 2014
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft guidance issued by the Food and Drug Administration (FDA) on April 9, 2014, entitled “Draft Guidance for Industry, Researchers, Patient...
May 30, 2014
April 10, 2014   BY ELECTRONIC DELIVERY   Marilyn B. Tavenner Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200...
May 27, 2014
BIO appreciates FDA’s efforts to further clarify labeling practices for products approved under the Accelerated Approval pathway. BIO strongly supported provisions under the Food and Drug Administration Safety and Innovation Act of 2012 (...
May 20, 2014
The importance of supporting biomedical research and innovation and the development of new therapies cannot be overstated. Today, we face increasing competition around the globe to overtake U.S. world leadership in biomedical innovation. Even in...
May 20, 2014
BIO commends FDA for releasing this revision of the 2000 Draft Guidance for Industry entitled “Analytical Procedures and Methods Validation” with its strong focus on regulatory science and modernization. We note that the emphasis on...
May 16, 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in...
May 9, 2014
The Biotechnology Industry Organization (BIO) is a trade association representing over 1,100 companies, academic institutions, and biotechnology centers. BIO members are involved in the research and development of biotechnological healthcare,...
May 9, 2014
The Biotechnology Industry Organization (“BIO”) is the world’s largest biotechnology trade association, representing over 1,100 companies, academic institutions, and biotechnology centers in all 50 states and in countries...
May 9, 2014
BIO commends FDA on the release of this Draft Guidance, which will help to increase the efficiency of early clinical research for, and ultimately facilitate the development of, cellular and gene therapy (CGT) products. In general, the Draft...
May 9, 2014
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) submit these comments in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry on Providing...
May 8, 2014
The Biotechnology Industry Organization (BIO) is the country’s largest biotechnology trade organization, representing over 1100 companies, academic institutions, and biotechnology centers in all 50 States and countries around the world.1 BIO...
May 2, 2014
As with the FDA’s previous Guidance on this topic (2009 Guidance), BIO continues to support FDA‘s clarification of its views on the dissemination of medical journal articles and medical or scientific reference publications that contain...