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Regulatory Affairs

BIO's 2013 Legislative Priorities
January 21, 2013

Brent Del Monte, BIO’s Vice President of Federal Government Relations, discusses the...

Building Biotech Hubs; Biomanufacturing Attractors and Accelerators
July 19, 2012

Bioscience economic development in a nation as large and diverse as the United States is as...

Andrew Emmett on PDUFA and the 2012 BIO International Convention
April 12, 2012

Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important...

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...

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Letters, Testimony & Comments

BIO's letter to FL Governor Scott Regarding Substitution of Biosimilar Medicines
May 8 2013
The Honorable Rick Scott Office of the Governor State of Florida 400 S. Monroe St. Tallahassee, FL 32399-0001 Dear Governor Scott...
PBRER: BIO Comments on Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
May 8 2013
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for...
Benefit-Risk: BIO Comments on FDA's Prescription Drug User Fee Act V Benefit-Risk Plan
May 7 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
Recombinant DNA: BIO Comments on WHO Guidelines on the Quality, Safety, and Efficacy of Biological Medicinal Products Prepared by Recombinant DNA Technology
April 19 2013
  The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the “WHO Guidelines on the Quality...
Immunogenicity: BIO Comments on Draft Guidance on Immunogenicity Assessment for Therapeutic Protein Products
April 12 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
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Press Releases

BIO to Use ViS Analytics to Streamline Pediatric Clinical Research
May 7 2013
Washington D.C., May 7, 2013 --The Biotechnology Industry Organization (BIO) and the ViS Research Institute...
Biosimilars Bill Seeks To Notify Patients & Doctors of Changes to Prescriptions
April 3 2013
Washington, D.C. (April 2, 2013) –  The Biotechnology Industry Organization (BIO) and BioFlorida commend...
Governor McDonnell Signs First in Nation Biosimilars Bill; Patients To Be Notified If Doctor's Prescription Changed
March 21 2013
Washington, D.C. (March 21, 2013) – The Biotechnology Industry Organization (BIO) commends Virginia Governor...
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...
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