Letters, Testimony & Comments

August 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity...
August 8, 2014
June 30, 2014   BY ELECTRONIC DELIVERY   The Honorable Marilyn B. Tavenner Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G...
August 8, 2014
This Draft Guidance is related to the Drug Supply Chain Security Act (DSCSA), and is intended to aid trading partners in identifying a suspect product, to provide information on how to notify trading partners and FDA about illegitimate product,...
August 6, 2014
The Hon. Michelle K. Lee Deputy Under Secretary of Commerce Acting Director United States Patent and Trademark Office Via email to myriad-mayo_2014@uspto.gov Re: March 4, 2014, Guidance For Determining Subject Matter Eligibility Of Claims...
August 6, 2014
The panel’s decision could significantly impair drug and biotechnology development efforts. Patents exist to ensure that innovators can recover the investments needed to develop new technology. Pharmaceuticals and biologics often present the...
July 31, 2014
    July 17, 2014   BY ELECTRONIC DELIVERY   Mandy Cohen, M.D., MPH Acting Director, Center for Consumer Information and Insurance Oversight Centers for Medicare and Medicaid Services Department of Health and...
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(BIO) thanks the Food and Drug Administration (FDA, the Agency) for the opportunity to submit comments on the Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs....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 22, 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life...
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...