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Meeting the Pandemic Challenge

Thirty six thousand Americans die from seasonal flu each year, now there is additional threat a possible global avian flu pandemic.

Everywhere You Look Biotechnology Touches Your Life

Has a member of your family been vaccinated against hepatitis B? Do you know someone who has diabetes? Has anyone in your family had heart disease?

BIO Statement On Protecting Research and Research Participants

The public has a strong interest in protecting research and research participants. Federal policy must find the right balance in protecting participants while allowing critical research to continue.

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.

BIO Position Statement on Clinical Trial Registries and Dissemination of Clinical Trial Results

This document outlines BIO's principles on clinical trials.

Fact Sheet on Drug Importation

Rx Drug Importation Poses Immediate and Incalculable Risk to American Patients (Apr. 19, 2004)

Medicare Prescription Drug and Modernization Act of 2003 Fact Sheet

The Medicare conference agreement conforms closely to BIO's principles, and the association urges Congress to act quickly and send the bill to the White House for the president's signature.

Fact sheet on S. 54, the Greater Access to Affordable Pharmaceuticals Act of 2003

In the early weeks of the 108th Congress, two Senate bills, S. 54 and S. 7, were introduced that embrace the "Greater Access to Affordable Pharmaceuticals Act of 2003" (GAAP), formerly known in the 107th Congress as S. 812

Biotechnology, Public Health, and National Security

How the industry can develop biodefense products.

Preparedness for Pandemics and Biodefense

In the wake of the September 11 terrorist attacks, BIO surveyed the industry and found that many biotech companies were already working on defense projects or developing technologies useful for both conventional health care and for defense against biological, chemical and radiological/nuclear agents.

Statement on Ethical Use of Biotechnology: To Promote Public Health and National Security and to Fight Against Bioterrorism

To Promote Public Health and National Security and to Fight Against Bioterrorism

Health-Care Applications

Biotechnology tools and techniques open new research avenues for discovering how healthy bodies work and what goes wrong when problems arise.

Biotechnology's Impact on Diseases of the Elderly: A White Paper

As people age they walk a minefield of life-threatening and debilitating diseases.

Oversight of Gene Therapy

Position of the Biotechnology Industry Organization (BIO), regarding oversight of gene therapy

Confidentiality of Patient Medical Records

With the increasing computerization of medical records and the consolidation of the health care system, people have become more concerned about the potential threat to the confidentiality of individual health information.

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

Rx Open Activated to Report on Status of Pharmacies in Oklahoma
May 24 2013
Washington, D.C. – Rx Response elevated its status to Alert and has activated Rx Open in the aftermath of the...
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...
More Press Releases →