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Regulatory Affairs

Off-Label Use of Anticancer Therapies: Physician Prescribing Trends and the Impact of Payer Coverage Policy

Providers and policy makers must collectively address the profound effect the red-tape hassle can have on the practice of oncology.

Letters, Testimony & Comments

Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
February 27 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
February 19 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
BIO Principles on Patient Safety in the Substitution of Biologic Products
January 24 2013
Biologics are complex medicines manufactured from living organisms. Unlike traditional “small molecule” drugs, biologics are...
Statement in Opposition to North Dakota S. 2066
January 24 2013
The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association. BIO represents more than 1,...
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Press Releases

Ken Lisaius Named BIO's Vice President of Communications
January 23 2013
Washington, D.C. (January 23, 2013) –  The Biotechnology Industry Organization (BIO) announced that Ken...
BIO Strongly Opposes RFS Waiver Requests in Comments to EPA
October 9 2012
Any waiver of the RFS would have little to no effect on corn prices, but would certainly harm biofuel producers and...
Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO
February 9 2012
Patient Safety Must Remain Top Priority Washington, D.C. (February 9, 2012) — Biotechnology Industry...
BIO Comments on New Initiatives to Grow Nation’s Bioeconomy
September 16 2011
Washington, D.C. (September 16, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim...
Synthetic Biology’s Potential for Commercial Innovation Should Be Supported, BIO Argues
September 1 2011
WASHINGTON, D.C.(Sept. 1, 2011) – Research and development in synthetic biology is an evolution of...
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