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

Letter to Hector Barreto

May 13 2003
Administrator, U.S. Small Business Administration

BIO's comments regarding FDA's Guidance

May 7 2003

BIO responds to the President's Council on Bioethics

Apr 15 2003


Statement before the House Judiciary Subcommittee on the Courts, the Internet and Intellectual Property

Apr 3 2003

Comments FDA's Draft Guidance For Collection of Race and Ethnicity Data in Clinical Trials

Mar 28 2003

BIO Testimony on Project BioShield

Mar 27 2003
BIO Testimony Before The House Energy And Commerce Subcommittee On Health And The House Select Committee On Homeland Security Subcommittee On Emergency Preparedness And Response Regarding Project BioShield Act Of 2003.