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Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section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.

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