Letter in Opposition of H.R. 2427, to House Speaker Dennis Hastert

Jul 15 2003


Phyllis Gardner Testimony

Jul 10 2003
Chairman Bilirakis and Members of the Committee, I am pleased to testify before you today regarding technology transfer issues as they relate to the biotechnology industry.

Letter to Mr. Gary Jackson, Asst. Administrator for Size Standards, U.S. Small Business Administration

Jul 7 2003

Letter from 53 Senators Opposed to Importation

Jun 24 2003
53 Senators send letter opposing HR 2427, Pharmaceutical Market Access Act of 2003

Comments regarding FDA's Guidance For Industry on Continuous Marketing Applications

Jun 17 2003


Statement of Michael J. Werner, Esq.

Jun 12 2003


Risk Assessment of Observational Data

May 29 2003
BIO agrees that observational studies can be useful for evaluating safety signals. However, additional discussion is needed regarding the designs and statistical control, as well as effect sizes that warrant regulatory actions.

Premarketing Risk Assessments

May 29 2003
Given the range of indications and study treatments that BIO member companies are involved in, we wish to emphasize the importance of an empirical approach to risk assessment that tailors efforts to the specifics of each development program.

Risk Management

May 29 2003
FDA considers Risk Management to be a continuous process of (1) learning about and interpreting a product's benefits and risks, (2) designing and implementing interventions to minimize a product's risks, (3) evaluating interventions in light of new knowledge that is acquired over time, and (4) revising interventions when appropriate.

Letter to Sens. Judd Gregg and Edward Kennedy

May 19 2003
Supporting legislation that prohibits genetic discrimination