Health Care

This paper is an overview of a variety of ways that have been suggested to encourage innovation/research and development for diseases that are endemic to the developing world but not the developed world.

Daryl Pritchard talks about personalized medicine and how advances in biotechnology will make it possible to detect, treat and prevent disease in new ways.

In order to ensure that new pioneer biotechnology products continue to reach patients and physicians, any statutory pathway for the approval of follow-on biologics must protect patient safety and preserve incentives to innovate.

Biotechnology, the combination of biology and technology, includes biologic applications, diagnostic tools and businesses that improve everyday life by providing solutions to some of life's most vexing problems.

Authors: Henry Grabowski, Iain Cockburn, Genia Long, Richard Mortimer, Scott Johnson

Dr. Moira Gunn and David Ewing Duncan report from the BIO International Convention.

October 14 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format.  BIO welcomes this Draft Guidance to ensure appropriate consistency in the format and content of product labeling for all prescription drug products approved by the Agency.  
September 2 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Current Good Manufacturing Practices—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act.”
August 26 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices (Draft Guidance).
July 31 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “The Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities.”
July 22 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions; Draft Guidance for Industry and Food and Drug Administration Staff.”
October 1 2014
Relationships between life sciences industry and physicians lead to stronger R&D collaboration and educate health care providers
September 22 2014
Washington, D.C. (September 22, 2014) – BIO President and CEO James Greenwood joined AdvaMed President and CEO Stephen Ubl and PhRMA President and CEO John Castellani in a letter to CMS Administrator Marilyn Tavenner highlighting ongoing concerns about a potential lack of necessary context around the Sunshine data release.  
April 7 2014
The EXPIRE Act would extend tax credits that expired at the end of 2013, including several of importance to the biotechnology industry.