Life Sciences Regulatory Enforcement Resource Kit

Summary

This resource kit collects Practical Guidance resources addressing regulatory enforcement challenges faced by life sciences organizations. Life sciences organizations including pharmaceutical medical device, biotechnology companies, and others must navigate a highly regulated industry subject to oversight by very active federal and state administrative agencies including the U.S. Food and Drug Administration (FDA). This resource kit includes Practical Guidance materials including trackers, practice notes, state law surveys, a checklist, a template, a clause, and articles.