Regulatory Affairs

Brent Del Monte, BIO’s Vice President of Federal Government Relations, discusses the 113th Congress and BIO’s 2013 legislative priorities.

Bioscience economic development in a nation as large and diverse as the United States is as varied as the country itself.  A complex array of factors influence the allocation of resources and the nature of bioscience industry development.

Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important regulatory issues facing the industry, specifically PDUFA reauthorization, the FDA and regulation. Also, hear his programming highlights from the Achieving Regulatory Approval and Compliance Track at the upcoming 2012 BIO International Convention.

The 14th Annual BIO CEO & Investor Conference was held on February 13-14 in New York City at the Waldorf=Astoria

State governments in 2011 continued to see regional economic growth in the life sciences industry and in 2012 will increasingly focus attention on technology transfer and venture funding as mechanisms to increase private sector innovation related activities within their jurisdictions. Realizing that entrepreneurship is a key ingredient in economic development, states and localities are undertaking the support of programs that assist high technology businesses, and that capitalize on state regional presence of universities and federal laboratories.

BIO President & CEO Jim Greenwood and Tom Watkins, President & CEO of Human Genome Sciences and Chair of BIO’s Board of Directors, recently hosted a media briefing to recap our advocacy accomplishments in 2011 and lay out BIO’s policy priorities for 2012.

Biotechnology continues to hold the greatest promise to address many of the most critical issues facing our world.

BIO President and CEO Jim Greenwood congratulated the FDA and biopharmaceutical sponsors for making 35 novel new treatments available to patients in FY11.

While the U.S. leads in the area of biotechnology, there is no guarantee this competitive edge will continue.

Regulatory review processes are not keeping up with rapidly advancing science and are making the environment for developing new treatments and preventions for deadly and debilitating diseases more difficult.

The biotech industry has shrunk dramatically in recent years based primarily on the continued tight capital markets and increased aversion to risk on the part of investors.

A strong Network will bolster public awareness of the industry and encourage more investment dollars.

Society has tapped just a small fraction of the many potential uses and benefits of biotechnology.

Mankind's need to cure disease, combat hunger and discover new forms of energy has never been more urgent.

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.”
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.
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