Home

Health Care

BIO Principles on Follow-On Biologics

In order to ensure that new pioneer biotechnology products continue to reach patients and physicians, any statutory pathway for the approval of follow-on biologics must protect patient safety and preserve incentives to innovate.

The Complexities of Comparative Effectiveness
BIO Principles on Comparative Effectiveness
Biotechnology Solutions for Everyday Life

Biotechnology, the combination of biology and technology, includes biologic applications, diagnostic tools and businesses that improve everyday life by providing solutions to some of life's most vexing problems.

The Effect on Federal Spending of Legislation Creating a Regulatory Framework for Follow-on Biologics: Key Issues and Assumptions

Authors: Henry Grabowski, Iain Cockburn, Genia Long, Richard Mortimer, Scott Johnson

BioTech Nation Interview of Jim Greenwood

Dr. Moira Gunn and David Ewing Duncan report from the BIO International Convention.

Milestones in 2006-2007

What happens in Washington influences biotechnology progress every bit as much as what happens on Wall Street or in the lab.

Realizing the Value of FDA-Approved Therapies
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.

Letters, Testimony & Comments

BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter
March 1 2013
  BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter, submitted Friday,...
SMU: BIO Comments on Creating an Alternative Approval Pathway for Certain Drugs to Address Unmet Medical Need
March 1 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
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...
Medicaid, Children’s Health Insurance Programs, and Exchanges
February 21 2013
Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H....
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...
More Letters, Testimony & Comments →

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...
More Press Releases →