Regulatory Affairs

BIO will be co-hosting an event with the United States Patent and Trademark Office (USPTO) to celebrate the 30th anniversary of the issuance of U.S. patent 4,259,444 to Ananda Chakrabarty following the Supreme Court case, Diamond v. Chakrabarty, which held that Chakrabarty’s bioengineered bacterium was eligible for patenting.

A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of leading biotechnology companies shows that clinical development times – specifically the duration of Phase II and Phase III trials – are lengthening, while FDA review times have remained constant.

Mark Herzog, executive director of the Virginia Biotechnology Association recently discussed the success and challenges facing the burgeoning bioscience industry in his state.

"The Value Proposition for Cellulosic and Advanced Biofuels Under the Federal Renewable Fuel Standard" is forthcoming in the April 2011 Industrial Biotechnology Journal.

Current rules resulting from a 2003 Office of Hearings and Appeals decision have inhibited and interfered with the growth and survival of small private biotechnology companies and the development of promising technologies and products

The Agriculture Department has announced additional money for loan guarantees to support construction of new advanced biofuel biorefineries.

The Maryland initiative’s 10-year plan helps build biotech access to funding

BIOtechNOW talks to GEN's John Sterling regarding the upcoming BIO International Convention.

GEN's Editor-in-Chief John Sterling outlines his picks for the top ten "must attend" breakout sessions at the 2011 BIO International Convention.

As we celebrate World Health Day today, it is an opportunity to remember that vaccines represent one of the most important global health investments.

 John Carroll, editor of Fierce Biotech, shares what he won't miss at the 2011 BIO International Convention.

Fifteen years after Dolly, the first mammal to be cloned from an adult cell rather than an embryo, made headlines, the process of livestock cloning is increasingly gaining acceptance as a viable means of satisfying demand for sustainable food production.

Derek Gregg discusses biotech in WV – major growth areas, outlook for the future, and upcoming plans for the BIO International Convention.

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.