Health Care

Myths abound regarding data exclusivity and the ability of an innovator to extend the period of data exclusivity as provided in the health care reform bill passed by the U.S. House of Representatives and legislation currently under consideration in the Senate.

Dr. Targan explains how the biotech industry is using the biology of taste to create healthier sweeteners, block bitter tastes, and help make unpleasant-tasting medicines more palatable.

Youve probably heard the term pandemic a lot in the news today. What you might not know is that biotechnology researchers are working to create new vaccination options to help stop the next big pandemic before it starts.

What's a stem cell? Where does it come from? Learn more about how biotechnology is utilizing stem cells to create tomorrow's cures for today's diseases.

Personalized medicine will change the way patients are treated in the future - for the better. Learn more about personalized medicine - how it works, and why it could save consumers a lot of money.

This video provides a basic overview of biotechnology and its many applications in our daily lives.

Are biotech drugs really that different from traditional pharmaceuticals.  You bet they are.  Learn why here.

BIO President and CEO Jim Greenwood and BIO Board Chair Dr. Stephen Sherwin discuss the need to ensure that health care reform promotes and preserves innovation, particularly in a pathway for biosimilars and the use of comparative effectiveness data.

October 14 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format.  BIO welcomes this Draft Guidance to ensure appropriate consistency in the format and content of product labeling for all prescription drug products approved by the Agency.  
September 2 2014
 The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Current Good Manufacturing Practices—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act.”
August 26 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices (Draft Guidance).
July 31 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “The Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities.”
July 22 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions; Draft Guidance for Industry and Food and Drug Administration Staff.”
October 1 2014
Relationships between life sciences industry and physicians lead to stronger R&D collaboration and educate health care providers
September 22 2014
Washington, D.C. (September 22, 2014) – BIO President and CEO James Greenwood joined AdvaMed President and CEO Stephen Ubl and PhRMA President and CEO John Castellani in a letter to CMS Administrator Marilyn Tavenner highlighting ongoing concerns about a potential lack of necessary context around the Sunshine data release.  
April 7 2014
The EXPIRE Act would extend tax credits that expired at the end of 2013, including several of importance to the biotechnology industry.