Regulatory Affairs

A new federal recommendation could hinder innovations from biotechnology R&D by limiting gene patents and licenses.

Disease resistant animals, environmentally friendly livestock, pharmaceuticals produced by goats - are these really possible?

In 2010, a lessening of the regulatory burden on biotech startups looks promising.

Biosimilars, also known as follow-on biologics, may eventually expand access and provide patients a more affordable alternative to innovative, lifesaving medicines. 

Biofuels have the potential to play a critical role in addressing climate change

BIO supports all avenues of research to investigate therapies for debilitating diseases such as Parkinson's.

In this interview, BIO President and CEO Jim Greenwood explains the promise of stem cell research and why it is an important first step in bringing new therapies to patients.

BIO and its members engaged in animal biotechnology support a strong federal regulatory system to oversee development and approval of all genetically engineered (GE) animals and the products derived from them.

We have used the biological processes of microorganisms for 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products.

Today, the biotechnology industry is enjoying more success and influence than ever before. Our industry’s innovations continue to improve the lives of people worldwide, and the advancement of these innovations is supported by the work of BIO.

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

In June 2003, the Biotechnology Industry Organization (BIO) brought its annual convention to Washington, D.C., setting the stage for an unprecedented exchange of views and expectations between biotechnology leaders and our nation’s top public officials.

Letters, Testimony & Comments

June 19 2013
We understand the challenges that India faces with respect to healthcare and the innovative biotechnology industry stands ready to work with India to help address them.  
June 7 2013
BIO applauds the government of Brazil for taking steps towards developing regulatory requirements to ensure patients suffering from rare diseases have access to treatment.   
May 8 2013
BIO  urges Florida Governor Scott to sign House Bill 365 – a bill related to the substitution of biologic and biosimilar medicines – which recently passed out of the Legislature.
May 8 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format .”
May 7 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the FDA Draft Plan on “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making.”

Press Releases

June 7 2013
Oregon Governor John Kitzhaber signed legislation on Thursday, June 6 designed to address the regulatory issues related to the interchangeability of biological medicines.
May 7 2013
Pediatric research is essential to study the effects of new therapeutics in children.
April 3 2013
The Biotechnology Industry Organization (BIO) and BioFlorida commend the Florida Senate Committee on Health Policy for passage of Senate Bill 732 out of committee.
March 21 2013
In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicines.
January 23 2013
Ken Lisaius has been named Vice President of Communications at BIO.