General Information

Biostatistics and FDA Regulation: The Convergence of Science and Law

May 20, 2014 | Harvard University | Cambridge, MA


A Symposium Presented by DIA, FDLI and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. In collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst, The Harvard Clinical and Translational Science Center


Drugs, Diagnostics



About the Conference

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences.  Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.   Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, tee up the need for a fresh look at the way biostatistical principles inform federal health care policy, particularly at the FDA.  This one-day symposium will give attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, as well as explore issues at the intersection of statistical analysis and life sciences litigation.

Who Should Attend

  • Regulatory attorneys
  • Consultants
  • Law students
  • Academics
  • Government attorneys
  • Industry members who use clinical trials