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FDA Stakeholders Meeting

Dec 7 2001
Since its inception, PDUFA has worked. The law has led to reduced review and approval times. This has meant that patients have had access to new therapies and diagnostics faster. Put simply, this law has both changed and saved lives.

Letter to Carl B. Feldbaum, BIO President from Samual W. Bodman, Deputy Secretary of Commerce

Nov 15 2001
Regarding funding for the U.S. Patent and Trademark Office

BIO letter to J. Dennis Hastert

Nov 5 2001

Economic Fundamentals Sound: Deal-Making within the Biotechnology Industry

Oct 29 2001
At a time when national security is understandably monopolizing Congress's legislative calendar, as well as the energies of the federal agencies that regulate biotechnology, I am pleased to report that the biotechnology industry's fundamentals are sound.

Testimony of Stephen G. Sudovar President & CEO, EluSys Therapeutics, Inc.

Oct 23 2001
U.S. House hearing on biological warfare defense

Testimony of Una S. Ryan, Ph.D., President & CEO, AVANT Immunotherapeutics, Inc.

Oct 23 2001
U.S. House hearing on biological warfare defense

BIO letter to US House of Representatives Energy and Commerce Chairman Tauzin

Oct 1 2001
Outling BIO opposition to generic biologic and pediatric rule codification amendments on pediatric exclusity bill.

BIO letter to US House of Representatives Energy and Commerce Health Subcommittee Chairman Bilirakis

Oct 1 2001
Outlining BIO opposition to generic biologic and pediatric rule codification amendments on pediatric exclusivity bill

BIO Letter to Ontario Premier on Gene Patenting

Sep 26 2001
If you ignore or remove intellectual property protection on biotechnology products, then the next generation of predictive tests and medicines will never materialize.

BIO letter to Rep. Michael Bilirakis, Chairman, Energy & Commerce Cmte., Subcommittee on Health

Jul 26 2001
Regarding the proposed approval of generic biologics.