Regulatory Affairs

Scientific American will release the third annual Worldview: A Global Biotechnology Perspective at this year’s BIO International Convention.

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.

October 14 2014
The Biotechnology Industry Organization (BIO) welcomes the opportunity to provide comments to Public Consultation #65 published by the Board of Directors of the National Health Surveillance Agency on August 4, 2014 which proposes a new regulation defining the procedures and requirements for conducting clinical trials involving drugs in Brazil.
October 14 2014
The Biotechnology Industry Organization (BIO) welcomes the opportunity to provide comments to Public Consultation #8 published by the Brazilian Ministry of Health on August 14, 2014 which proposes a new regulation defining the guidelines and criteria for the submission, formation, monitoring and evaluation of PDP (Public-Private Productive Development Partnerships) projects.
October 14 2014
The Biotechnology Industry Organization (BIO) appreciates this fifth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin.
July 28 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA, the Agency) for the opportunity to submit comments on the Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs.
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.”
August 6 2014
Survey responses will help inform Prescription Drug User Fee Act VI negotiations
May 7 2014
Pediatric research is essential to study the effects of new therapeutics in children
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.
February 26 2014
Transparent communication important for Patients and Physicians
October 22 2013
Pending Legislation will Protect Indiana Citizens Utilizing Biologic Medications to Manage Chronic Diseases and other Unmet Medical Needs