In The News

Health Care and Life Sciences Attorneys Author Law360 Article on New FDA Informed Consent Guidance for Minimal Risk Research

Practices: Life Sciences, Health Care, FDA Regulatory, Clinical Research

Partner and co-chair of the life sciences practice Gregory Levine (Washington, D.C.), health care partner Mark Barnes (Boston), life sciences associate Abram Barth (New York), and health care associate David Peloquin (Boston) authored an Aug. 11 Law360 “Expert Analysis” article on the U.S. Food and Drug Administration’s (FDA) new informed consent guidance for certain minimal risk research.

The article outlines the new FDA policy on waiver of informed consent for institutional review boards monitoring clinical investigations and provides advice for medical companies and institutions conducting FDA-regulated research.