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Letters, Testimony & Comments

So you want to become a biotech CEO
January 17, 2003
When I read the agenda for today and saw the emphasis on corporate strategy, it reminded me of a quote by financier Victor Palmieri, who said: "Strategies are okayed in boardrooms that even a child would say are bound to fail. "The...
Pennsylvania Biotechnology Association
January 16, 2003
Thank you Dave. Dave Holveck is a good friend, and a forceful champion of our industry. I don't use the word "champion" lightly but few individuals in our industry - in any industry - have gotten back up off the mat after his company took a big...
Comments on Draft OIG Compliance Guidance
December 2, 2002
For Pharmaceutical Manufacturers
Letter, Concerns with Trade-Related Aspects of Intellectual Property (TRIPS)
November 27, 2002
Letter to The Honorable Robert Zoellick, US Trade Representative
BIO supports limited liability protection
November 18, 2002
The Honorable Tom Daschle 509 Hart Senate Office Building Washington DC 20510 Dear Senator Daschle: The Senate will very soon be asked to approve legislation creating a new Department of Homeland Security. However, as the Senate moves toward...
Festo v. SMC Corporation
November 16, 2002
Court Decision Invalidating FDA's Pediatric Rule
November 14, 2002
On October 17, 2002, Judge Henry H. Kennedy of the U.S. District Court for District of Columbia struck down FDA's "pediatric rule." Among other things, the rule allowed FDA to require that drug and biologics applications "...
Bioterrorism: A Challenge We Cannot Decline to Meet
November 6, 2002
Carl B. Feldbaum, BIO President Since its inception in the 1970's, the biotechnology industry's mission has been to improve and save human lives. The industry has followed through on that commitment with more than 120 new drugs and...
Letter on the PTO's strategic plan and their fee restructuring proposal
October 24, 2002
The Honorable Mitchell E. Daniels, Jr. Director, Office of Management and Budget Dwight D. Eisenhower Executive Office Building, #252 17th Street and Pennsylvania Avenue, N.W. Washington, D.C. 20503 Dear Director Daniels: We are writing to...
FDA Letter Opposing Oregon Measure 27
October 4, 2002
Dear Governor Kitzhaber: This letter explains why FDA objects to the pending ballot initiative to require the mandatory labeling of foods and food additives produced using genetic engineering sold in Oregon, or produced in Oregon and shipped to...
FDA Letter Opposing Oregon Measure 27
October 4, 2002
Sent to Governor Kitzhaber (October 4, 2002).
Letter Supporting HR 2215
October 2, 2002
Dear Senator Daschle: The Biotechnology Industry Organization (BIO) strongly supports the Conference Agreement on the Department of Justice Authorization Act (HR 2215) and urges passage by the U.S. Senate. The House of Representatives passed the...
Letter Opposing H. Res. 517
September 20, 2002
Letter from BIO to the U.S. House of Representatives strongly urging members not to sign the discharge petition (H. Res. 517) offered by the Democratic leadership that would bring the "Greater Access to Affordable Pharmaceuticals Act of 2001...
The Application of Industrial Biotechnology to Pollution Prevention
September 19, 2002
First Amendment Request for Comment
September 13, 2002
Required Notification of Possession/Non-Possession of Select Agents Deadline
August 8, 2002
BIO members should immediately become familiar with provisions of the Public Health Security and Bioterrorism Response Act of 2002 (Pub. L. No. 107-188) that require facilities in possession of select agents or high consequence livestock pathogens...
Letter from Jim Rogan, USPTO Director Opposing S. 812
July 30, 2002
BIO Statement on Proposed PTO Fee Restructuring
July 25, 2002
Response to Sen. Ted Kennedy
July 22, 2002
In Depth Legal Analysis of Proposed PTO Fee Restructuring
July 17, 2002