Regulatory Affairs

Tracy Cooley talks to Renee Winsky about biotech in Maryland and the upcoming  BIO International Convention  in Washington, DC.

All programs at the BIO World Congress on Industrial Biotechnology and Bioprocessing are open to attendance by members of the media. Complimentary media registration is available to editors and reporters with valid press credentials working full time for print, broadcast or web publications.

Despite the fact that U.S. Secretary of Agriculture Tom Vilsack believes that the regulation of genetically engineered agricultural products must be science-based, and that he has “no doubts about the safety of the products this system has approved and will continue to approve,” some state legislatures are considering bills requiring labeling for biotech-derived food. These bills defy existing science-based regulation and are wholly unnecessary.

BIO released a white paper on the growth and jobs potential of green chemicals.

The advanced biofuel industry can reduce reliance on oil and create green jobs; diverse federal programs are necessary to help producers secure financing for construction of projects. The Biotechnology Industry Organization (BIO) today joined 34 other companies and trade associations to ask leaders of the House Ways and Means Committee to include the language of H.R. 5142, the Grow a Renewable Energy Economy Now – Jumpstart Other Biofuels (GREEN JOB) Act of 2010, in the next appropriate revenue vehicle considered by the House.

The federal Renewable Fuel Standard provides the stable policy essential to attracting private investment to the development of advanced biofuels. The Biotechnology Industry Organization (BIO) today joined the Advanced BioFuel Association, the Renewable Fuel Association, the Advanced Ethanol Council and the American Coalition for Ethanol in a letter to leaders of the House Committee on Energy and Commerce and the Senate Committee on Environment and Public Works urging protection of the federal RFS.

BIO is committed to increased access to biologic medicines for patients throughout the world. 

Emerging biotech companies with promising scientific innovation need a policy environment that will enable them to continue critical research and development of medical advancements and breakthroughs.

Providing legal counsel within the biotech industry comes with a unique set of challenges.  Legal professionals must consistently stay on top of the latest policy and regulatory changes within the industry. From patent issues to new laws on licensing to regulations for new innovations, the BIO International Convention (June 27-30) will feature the latest updates, insights and networking opportunities—plus educational sessions where you can earn up to eight CLE credit hours—to help fast-track your career. Sit in on any number of BIO Program presentations by leading law firms and earn CLE credits.

You might have heard that the Prince of Wales, just days after hosting the Royal Wedding, paid us a visit here in Washington.  Prince Charles, a long-time organic food advocate and self-described environmentalist, was here to speak at a Washington Post symposium on the Future of Food.

Recently introduced legislation could help the military become the technology leader in scaling up commercial production of sustainable biofuels, such as algae.

The world’s largest biotech hubs are busy planning their delegations’ visits to the  BIO International Convention  next month. The international program at the Convention will be one of the most robust to date, with International Case Studies, breakout sessions focused on globalization and Super Sessions focused on the emerging markets.

During today’s plenary lunch session at BIO's 2011 World Congress in Toronto, Royal DSM CEO Feike Sijbesma gave a passionate keynote address and accepted the 2011 George Washington Carver Award for his company’s efforts to promote bio-based products over those relying on fossil-fuel resources.

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.”
November 20 2013
BIO welcomes the opportunity to provide the views of its members on facilitating access to genetic resources and traditional knowledge and the sharing of benefits from their use...
November 18 2013
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 Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products.”  
November 5 2013
BIO thanks FDA for releasing this Draft Guidance specifying the Data Universal Numbering System (DUNS) number as FDA’s preferred Unique Facility Identifier (UFI) system in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA) sections 701 and 702.  BIO supports FDA’s effort to have a single facility identification system in order to facilitate FDA’s activities that follow-on to registration which help secure patient and consumer safety, and we have several recommendations and requests for clarification on the proposal put forth in the Draft Guidance.
September 23 2013
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 Pre-Launch Activities Importation Requests.”  
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
September 5 2013
Jim Greenwood, President and CEO of BIO, issued the following statement on the California Senate's passage of Senate Bill 598.
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.