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.

March 14 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the "Proposed Rule: Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products."
March 10 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the docket regarding “Complex Issues in Developing Drug and Biologics Products for Rare Diseases.” Comments are being provided in two areas; general comments on the challenges of rare disease drug development, and specific comments in response to the public workshop.
March 4 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Request for Nominations: Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.”
February 3 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 Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act.”
January 31 2014
The Biotechnology Industry Organization (BIO) respectfully submits these comments in response to the Generic Pharmaceutical Association (GPhA) Citizen Petition requesting the Food and Drug Administration (FDA) to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition).
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.
March 25 2014
The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) commend Indiana Governor Mike Pence for signing legislation today designed to create a pathway for the substitution of interchangeable biologic medicines.
March 5 2014
Many of the provisions included in this budget proposal would jeopardize the continued biotech research and development that is necessary to find cures and breakthrough medicines for patients living with debilitating and life-threatening diseases. 
January 30 2014
Patients Should Be Informed if Doctor's Prescription Changed