Food and Drug Administration

Science Board to the Food and Drug Administration

April 15, 2005

Slides

Introduction to Drug Safety, Steven Galson, MD, MPH (HTM) (PPT)

Pre-Marketing Safety Assessment: The Safety Review Guidance, Amando Oliva, MD (HTM) (PPT)

Labeling and Electronic Initiatives, Rachel Behman, MD, MPH (HTM) (PPT)

Drug Safety Initiative, Steven Galson, MD, MPH (HTM) (PPT)

Post-Market Drug Safety, Paul Seligman, MD MPH (HTM) (PPT)

Estimating CDER Resources Devoted to Safety, Theresa Mullin, PhD (HTM) (PPT)

Applying New Science to Drug Safety, Janet Woodcock, MD (HTM) (PPT)

Meeting the Challenges of Blood, Vaccine, and Tissue Safety, Jesse Goodman, MD, MPH (HTM) (PPT)

Current Good Manufacturing Practice: Vaccines, Mary Malarkey (HTM) (PPT)

Open Public Hearing

List of Scheduled Speakers (PDF)

The Reduction of Animal Use in regulatory Testing, Sadhana Dhruvakumar, PETA (PDF) (PPT)

Comments of Consumers Union, Janell Duncan (PDF)

Technology Options for RFID in Pharma, Paul Drzaic, PhD, Alien Technology Cor. (PDF) (PPT)

America's Blood Centers, G. Fitzpatrick, PhD (PDF)

NSF Cyber Infrastructure, Sangtae Kim, PhD (HTM) (PPT)

Biographical Sketch, Santae Kim, Purdue University (PDF)

American Academy of Child & Adolescent Phychiatry, Richard Sarles, MD and the American Psychiatric Association, James Scully, MD (PDF)