"This portfolio analyzes the federal regulatory framework within which the life sciences industry must function. The portfolio is also intended to serve as a practical guide on the fundamentals of life sciences compliance by addressing subject areas such as FDA regulatory compliance in both the pre-market and post-market settings, health care regulatory compliance, white collar compliance beyond the FDA (anti-kickback statute, False Claims Act, and Foreign Corrupt Practices Act), and general compliance under Sarbanes-Oxley and Dodd-Frank as applied to the life sciences industry."
Authors: Michael M. Gaba, Michael J. Werner, William F. Gould, .
Bibliography, etc. Note
Includes bibliographical references.
Formatted Contents Note
Introduction to pre-market and post-market compliance Pre-market environment Clinical trials Compliance straddling the pre-market and post-market environments Statutory and regulatory obligations under the Physician Payment Sunshine Act Post-market compliance Healthcare and general compliance applied to the life sciences industry Daily compliance: a practical guide Working papers.
Digital File Characteristics
Source of Description
Title from title screen (viewed Aug. 11, 2014).
Available in Other Form
Print version: Gaba, Michael M. Life sciences compliance. Arlington, VA : Bureau of National Affairs, -