FDA Issues Final Guidance on Clinical Trial IRBs

On Tuesday, August 27th, the FDA finalized its Guidance for Institutional Review Boards, Clinical Investigators and Sponsors on Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is NeededContinue reading

Have questions about GMO. Check out GMO Answers.

BIO has launched a new initiative called “GMO Answers” that will reach out to the American people, engage with them, embrace their curiosity and skepticism, and answer their questions about how our food is grown – in particular questions they may have about the use of “genetically modified organisms,” or GMOs.Continue reading








Dear President Obama & Members of the 113th Congress:

Our nation’s role as the world’s innovation leader is in serious jeopardy.  The combination of eroding federal investments in research and higher education, additional cuts due to sequestration, and the enormous resources other nations are pouring into these areas is creating a new kind of deficit for the United States: an innovation deficit.  Closing this innovation deficit—the widening gap between needed and actual investments—must be a national imperative.

Ignoring the innovation deficit will have serious consequences: a less prepared, less highly skilled U.S. workforce, fewer U.S.-based scientific and technological breakthroughs, fewer U.S.-based patents, and fewer U.S. start-ups, products, and jobs.  These impacts may not be immediately obvious because the education and research that lead to advances do not happen overnight.  But the consequences are inevitable if we do not reverse course.

The path for resolving appropriations, the debt limit, and a potential long-term budget agreement this fall is unclear.  What should be clear is that the answer to our nation’s fiscal woes must include sustained strategic federal investments in research and student financial aid to close the innovation deficit and bolster our nation’s economic and national security for decades to come.

More than half of U.S. economic growth since World War II is a consequence of technological innovation, overwhelmingly resulting from federally-funded scientific research.  Such groundbreaking research has led to life-saving vaccines, lasers, MRI, touchscreens, GPS, the Internet, and many other advances that have improved lives and generated entire new sectors of our economy.  Many of the university researchers making those discoveries would not have the opportunity to be in their labs were it not for federal support of research and higher education.

Having witnessed this nation’s success at turning investments in research and higher education into innovation and economic growth, countries such as China, Singapore, and Korea have dramatically increased their own investments in these areas.  Over the past decade these other nations’ investments have climbed at two to four times the rate of U.S. research and development expenditures.  It is equally troubling that the U.S. has fallen to 16th among developed countries in the share of young adults who hold college degrees.  Our nation is rapidly losing ground, and further cuts including sequestration will only exacerbate the problem.

Because the innovation deficit undermines economic growth it harms our nation’s overall fiscal health, worsening long-term budget deficits and debt.  Investments in research and education are not inconsistent with long-term deficit reduction; they are vital to it.

Throughout our history, this nation has kept the promise of a better tomorrow to each generation.  This has been possible because of our economic prosperity based in large part on America’s role as global innovation leader. Failing to deal with the innovation deficit will pass to future generations the burdens of lost leadership in innovation, economic decline, and limited job opportunities.

We call upon you to reject unsound budget cuts and recommit to strong and sustained investments in research and education.  Only then can we ensure that our nation’s promise of a better tomorrow endures.


Hunter R. Rawlings III, Association of American Universities
Peter McPherson, Association of Public and Land-grant Universities
Kenneth E. Peacock, Appalachian State University
Michael Crow, Arizona State University
Jay Gogue, Auburn University
Harvey G. Stenger, Binghamton University, The State University of New York
Robert W. Kustra, Boise State University
Robert A. Brown, Boston University
Mary Ellen Mazey, Bowling Green State University
Frederick M. Lawrence, Brandeis University
Christina H. Paxson, Brown University
Edward Stolper, California Institute of Technology
Jeffrey D. Armstrong, California Polytechnic State University, San Luis Obispo
J. Michael Ortiz, California State Polytechnic University, Pomona
Timothy P. White, California State University
Richard R. Rush, California State University Channel Islands
Paul J. Zingg, California State University, Chico
Willie J. Hagan, California State University, Dominguez Hills
Leroy M. Morishita, California State University, East Bay
John D. Welty, California State University, Fresno
Mildred García, California State University, Fullerton
Donald J. Para, California State University, Long Beach
James M. Rosser, California State University, Los Angeles
Dianne F. Harrison, California State University, Northridge
Alexander Gonzalez, California State University, Sacramento
Tomás D. Morales, California State University, San Bernardino
Karen S. Haynes, California State University San Marcos
Subra Suresh, Carnegie Mellon University
Barbara R. Snyder, Case Western Reserve University
Lisa S. Coico, The City College of New York
William Kelly, The City University of New York
James F. Barker, Clemson University
Ronald M. Berkman, Cleveland State University
Anthony A. Frank, Colorado State University
Michael V. Martin, Colorado State University System
Lee C. Bollinger, Columbia University
Mortimer H. Neufville, Coppin State University
David J. Skorton, Cornell University
Harry L. Williams, Delaware State University
Richard H. Brodhead, Duke University
Steven Ballard, East Carolina University
James W. Wagner, Emory University
Mark B. Rosenberg, Florida International University
Eric Barron, Florida State University
G.P. “Bud” Peterson, Georgia Institute of Technology
Drew Gilpin Faust, Harvard University
Michael A. McRobbie, Indiana University
Charles R. Bantz, Indiana University-Purdue University Indianapolis
Steven Leath, Iowa State University
Ronald J. Daniels, Johns Hopkins University
Kirk H. Schulz, Kansas State University
Lester A. Lefton, Kent State University
Mary Evans Sias, Kentucky State University
L. Rafael Reif, Massachusetts Institute of Technology
David Hodge, Miami University
Lou Anna K. Simon, Michigan State University
Glenn D. Mroz, Michigan Technological University
Mark E. Keenum, Mississippi State University
Cheryl B. Schrader, Missouri University of Science and Technology
Waded Cruzado, Montana State University
Susan A. Cole, Montclair State University
Joel S. Bloom, New Jersey Institute of Technology
Garrey Carruthers, New Mexico State University
John Sexton, New York University
William Woodson, North Carolina State University
Dean L. Bresciani, North Dakota State University
John D. Haeger, Northern Arizona University
Douglas D. Baker, Northern Illinois University
Betty J. Youngblood, Oakland University
Joseph A. Alutto, The Ohio State University
Roderick J. McDavis, Ohio University
Edward J. Ray, Oregon State University
Rodney A. Erickson, The Pennsylvania State University
Wim Wiewel, Portland State University
Christopher L. Eisgruber, Princeton University
David Leebron, Rice University
Robert L. Barchi, Rutgers, The State University of New Jersey
Elliot Hirshman, San Diego State University
Leslie E. Wong, San Francisco State University
Ruben Arminana, Sonoma State University
David L. Chicoine, South Dakota State University
Rita Cheng, Southern Illinois University Carbondale
Glenn Poshard, Southern Illinois University System
Nancy L. Zimpher, The State University of New York
Samuel L. Stanley, Jr., Stony Brook University, State University of New York
Neil D. Theobald, Temple University
R. Bowen Loftin, Texas A&M University
M. Duane Nellis, Texas Tech University
Scott S. Cowen, Tulane University
Gilbert Rochon, Tuskegee University
Robert J. Jones, University at Albany SUNY
Luis Proenza, The University of Akron
Robert E. Witt, The University of Alabama System
Tom Case, University of Alaska Anchorage
Brian Rogers, University of Alaska Fairbanks
John R. Pugh, University of Alaska Southeast
Patrick Gamble, University of Alaska System
Ann Weaver Hart, The University of Arizona
G. David Gearhart, University of Arkansas
Laurence B. Alexander, University of Arkansas at Pine Bluff
Donald R. Bobbitt, University of Arkansas System
Satish K. Tripathi, University at Buffalo, The State University of New York
Mark G. Yudof, University of California
Nicholas B. Dirks, University of California, Berkeley
Linda P.B. Katehi, University of California, Davis
Michael V. Drake, University of California, Irvine
Gene Block, University of California, Los Angeles
Dorothy Leland, University of California, Merced
Jane Close Conoley, University of California, Riverside
Pradeep  Khosla, University of California, San Diego
Susan Desmond-Hellmann, University of California, San Francisco
Henry T. Yang, University of California, Santa Barbara
George Blumenthal, University of California, Santa Cruz
John C. Hitt, University of Central Florida
Santa J. Ono, University of Cincinnati
Donald M. Elliman, Jr., University of Colorado Denver | Anschutz Medical Campus
Philip P. DiStefano, University of Colorado Boulder
Patrick T. Harker, University of Delaware
James E. Lyons, Sr., University of the District of Columbia
Bernie Machen, University of Florida
Jere W. Morehead, The University of Georgia
MRC Greenwood, University of Hawaii System
Tom Apple, University of Hawaii at Manoa
Renu Khator, University of Houston
Robert A. Easter, University of Illinois
Paula Allen-Meares, University of Illinois at Chicago
Phyllis M. Wise, University of Illinois at Urbana-Champaign
Sally Mason, The University of Iowa
Bernadette Gray-Little, The University of Kansas
Eli Capilouto, University of Kentucky
Paul W. Ferguson, The University of Maine
Wallace D. Loh, University of Maryland
William E. Kirwan, University System of Maryland
Robert L. Caret, University of Massachusetts
Kumble R. Subbaswamy, University of Massachusetts Amherst
Mary Sue Coleman, University of Michigan
Eric W. Kaler, University of Minnesota
Lendley C. Black, University of Minnesota Duluth
Brady J. Deaton, University of Missouri
Tim M. Wolfe, University of Missouri System
Leo E. Morton, University of Missouri-Kansas City
Thomas F. George, University of Missouri-St. Louis
Royce C. Engstrom, University of Montana
James B. Milliken, University of Nebraska
Neal J. Smatresk, University of Nevada, Las Vegas
Marc A. Johnson, University of Nevada, Reno
Mark W. Huddleston, University of New Hampshire
Robert G. Frank, The University of New Mexico
Carol L. Folt, The University of North Carolina at Chapel Hill
Philip L. Dubois, University of North Carolina at Charlotte
Linda P. Brady, University of North Carolina at Greensboro
Gary L. Miller, University of North Carolina at Wilmington
Thomas W. Ross, The University of North Carolina System

V. Lane Rawlins, University of North Texas
V. Burns Hargis, Oklahoma State University
Michael R. Gottfredson, University of Oregon
Amy Gutmann, University of Pennsylvania
Mark A. Nordenberg, University of Pittsburgh
David M Dooley, University of Rhode Island
Joel Seligman, University of Rochester
Harris Pastides, University of South Carolina
James W. Abbott, University of South Dakota
Judy Genshaft, University of South Florida
C. L. Max Nikias, University of Southern California
Joe DiPietro, The University of Tennessee
Jimmy G. Cheek, University of Tennessee, Knoxville
Vistasp M. Karbhari, University of Texas at Arlington
William Powers, Jr., University of Texas at Austin
David E. Daniel, University of Texas at Dallas
Diana Natalicio, University of Texas at El Paso
Francisco Cigarroa, The University of Texas System
Lloyd A. Jacobs, The University of Toledo
E. Thomas Sullivan, The University of Vermont
Teresa A. Sullivan, University of Virginia
Michael K. Young, University of Washington
Kevin P. Reilly, University of Wisconsin System
Rebecca Blank, University of Wisconsin-Madison
Michael Lovell, University of Wisconsin-Milwaukee
Bob Sternberg, University of Wyoming
Stan L. Albrecht, Utah State University
Nicholas S. Zeppos, Vanderbilt University
Michael Rao, Virginia Commonwealth University
Charles W. Steger, Virginia Tech
Elson S. Floyd, Washington State University
Mark S. Wrighton, Washington University in St. Louis
Allan Gilmour, Wayne State University
James P. Clements, West Virginia University
John M. Dunn, Western Michigan University
Peter Salovey, Yale University