Regulatory Affairs

BIOtechNow’s Tracy Cooley discusses biotech in West Virginia – major growth areas, outlook for the future, and upcoming plans for the BIO International Convention – with Derek Gregg.

Patent systems can provide an advantage to society by rewarding the development of new inventions, promoting the advancement of technology and protecting the investor.  Patents often are the most important, and sometimes only, asset of a biotech company. Patents and related rights must be obtained in a timely and predictable manner and the ability to enforce those patents is critical.

The Massachusetts Life Sciences Center, which is tasked with administering the $1 billion state's life sciences initiative, has awarded five loans to start up companies, totaling $3.75 million.

Overhauled BIOTradeStatus lets users search for the latest information on hundreds of products.

Budget victories will help biotechnology in the Commonwealth

The Patent Reform Act of 2011 would strengthen and improve our nation’s patent system, spurring innovation and job creation.

Industry leaders point out that biotech-enabled advanced biofuels spur job growth and reduce U.S. dependence on imported oil.

The government’s Qualifying Therapeutic Discovery Project Program is doing what it was intended to do, according to a recent survey of senior executives at small biotechnology companies.

Scientific American will release the third annual Worldview: A Global Biotechnology Perspective at this year’s BIO International Convention.  Created in partnership with BIO, the publication explores the diverse economic regions of the world, highlighting success stories, policy achievements, cutting-edge science and the unique challenges that lie ahead. This year’s report focuses on BRIC (Brazil, Russia, India and China) country efforts to build local biotechnology hubs. 

Agency issues partial deregulation of Roundup Ready sugar beets while it prepares an environmental impact statement.

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market?

On April 8, 2004, Genentech, Inc. filed a Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA) with respect to a biotechnology product that relies, directly or indirectly, on trade secret and confidential commercial data and information of an innovator.

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.”  
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
September 5 2013
Jim Greenwood, President and CEO of BIO, issued the following statement on the California Senate's passage of Senate Bill 598.