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Regulatory Affairs

Panelists Go Inside the FDA at the BIO CEO & Investor Conference
February 22, 2012

The 14th Annual BIO CEO & Investor Conference was held on February 13-14 in New York City...

Successful State Initiatives That Encourage Bioscience Industry Growth
February 9, 2012

State governments in 2011 continued to see regional economic growth in the life sciences...

Podcast: BIO Media Briefing Highlights 2012 Policy Priorities
January 25, 2012

BIO President & CEO Jim Greenwood and Tom Watkins, President & CEO of Human Genome...

2011: A Pivotal Year for Biotechnology
December 22, 2011

Biotechnology continues to hold the greatest promise to address many of the most critical...

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Letters, Testimony & Comments

Orphan Drugs: BIO Submits Comments on Orphan Drug Regulations
January 17 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
Bar Code Technologies: BIO Comments on FDA's Bar Code Technologies for Drugs and Biological Products; Retrospective Review under Executive Order 13563
January 9 2012
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA...
Biologics: EMA Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substance: Non-clinical and Clinical Issues
December 31 2011
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on...
Drug Shortages: BIO Comments on Center for Drug Evaluation and Research (CDER), Approach to Addressing Drug Shortage; Public Workshop; Request for Comments
December 23 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
Biosimilar User Fees: BIO Testifies at Biosimilar User Fee Public Hearing
December 16 2011
Dear Sir/Madam: On behalf of the Biotechnology Industry Organization, thank you for the opportunity to comment on the proposed user fee...
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Press Releases

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...
BIO Unveils Strategic Initiative to Speed Scientific Breakthroughs, Develop Cures and Grow the Bio-Economy
June 29 2011
WASHINGTON, D.C. (Wednesday, June 29, 2011) - The Biotechnology Industry Organization (BIO) released today a summary...
Illinois Governor Pat Quinn Selected as BIO Governor of the Year
June 9 2011
WASHINGTON, D.C. (Thursday, June 09, 2011) - The Biotechnology Industry Organization (BIO) announced today its...
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