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Methodological Challenges Associated with Meta-Analyses in Health Care and Behavioral Health Research
May 17, 2013

Meta-analysis is used to inform a wide array of questions ranging from pharmaceutical safety...

Update Vaccine Excise Tax to Cover New Approvals
April 26, 2013

S.391 and H.R. 475 update the existing excise tax to cover newly approved season flu vaccines...

Dr. Trevor Mundel, President Global Health, Gates Foundation
April 24, 2013

At the 2013 BIO International Convention, Mundel discusses biotech start-ups and how biotech...

Dr. Richard Mohs, Distinguished Research Fellow, Eli Lilly
April 24, 2013

Dr. Richard Mohs, Distinguished Research Fellow, Eli Lilly discusses the importance of early...

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Letters, Testimony & Comments

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Immunogenicity: BIO Comments on Draft Guidance on Immunogenicity Assessment for Therapeutic Protein Products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...
Sunshine: BIO Files Comments on Estimated Burden of complying with Section 6002 of the Affordable Care Act (“the Sunshine Act”)
April 8 2013
BIO supports the goals of the Affordable Care Act (ACA) in providing greater transparency regarding financial relationships with...
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Press Releases

BIO Praises U.S. Senate for Passing the Pandemic and All-Hazards Preparedness Reauthorization Act
February 28 2013
WASHINGTON, DC – February 28, 2013 –The Biotechnology Industry Organization (BIO) lauds the Senate for...
BIO Praises The House of Representatives for Approving H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act
January 25 2013
The Biotechnology Industry Organization lauds the House of Representatives for passing H.R. 307, the Pandemic and All...
PDUFA V Sets New Course for Regulatory Science – Joint BIO/PhRMA Statement
October 1 2012
Washington, D.C. (October 1, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and...
IFPMA, BIO and WADA Advance Anti-Doping Collaboration with the Launch of 2 Fields 1 Goal Campaign
July 23 2012
Groups Issue Booklet to Help Biotechnology and Pharmaceutical Companies Identify Pipeline Medicines with Doping...
Supreme Court Affordable Care Act Ruling Must Now Lead to Implementation That Will Promote Innovation and Expand Access
June 28 2012
  Pleased to move forward on biosimilars pathway Washington, D.C. (June 28, 2012) –Biotechnology...
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