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.

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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices (Draft Guidance).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Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions; Draft Guidance for Industry and Food and Drug Administration Staff.”
June 9 2014
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft guidance issued by the Food and Drug Administration (FDA) on April 9, 2014, entitled “Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff: Meetings with the Office of Orphan Products Development.”
May 27 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.
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.
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.
March 5 2014
Many of the provisions included in this budget proposal would jeopardize the continued biotech research and development that is necessary to find cures and breakthrough medicines for patients living with debilitating and life-threatening diseases. 
January 30 2014
Patients Should Be Informed if Doctor's Prescription Changed