Amy Bauer
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Amy Bauer Posted on : Insider Community

New Second Edition of Pharmaceutical and Medical Device Compliance Manual


Gain real-life insights and perspectives on creating, managing, and monitoring an effective compliance program in today’s complex enforcement and business environment with a new edition from AHLA and Seton Hall Law.

In Pharmaceutical and Medical Device Compliance Manual, Second Edition you’ll find

  • Updates on enforcement of the Controlled Substances Act, Open Payments Program, Foreign Corrupt Practices Act, Federal Travel Act, Fraud laws and more
  • Updated enforcement guidance, including advisory opinions, safe harbors, advisory bulletins and more. Updated table of settlements, including allegations and settlement terms.
  • Updated analysis of materiality and falsity post-Escobar, recent whistleblowing and enforcement trends, state false claims acts
  • Presentation of risk information in consumer-directed print advertisements, FDA Guidance on “Consistent Communications,” new analysis of communications regarding off-label and unapproved new uses in journals, medical texts, clinical practice guidelines, guidance on communications with payers and formulary committees and more
  • Updated Chapter 5 and expanded to address biologics, software, drug-device combination products, human cells, tissue, and tissue-based products, and virtual clinical trials, as well as the federal 21st Century Cures Act and Right to Try Act
  • Updates relating to the 340B Drug Discount Program, and more
  • Expanded discussion of international laws, including jurisdiction, penalties, and numerous enforcement actions
  • Recent developments in U.S. enforcement policy and updates on enforcement actions
  • Sources of guidance on compliance programs
  • Completely new in-depth analysis of the impact of HIPAA, HITECH, and GDPR and how they apply to specific life sciences activities
  • New analysis of the Sunshine Act’s requirements and exemptions.
  • Updates on state disclosure and lobbyist laws.
  • Updated analysis of government, private, and international resources that can help guide the creation of an effective compliance program
  • All new chapter examining significant challenges for manufacturers in light of the complicated distribution system, multiple federal programs, and dynamic nature of the pricing environment.
  • All New chapter addressing the role and function of patient organization and industry guidelines for partnering with these groups.
  • All New compliance analytics analysis
  • All New framework to assist compliance officers with reducing risk while maximizing business opportunity in a complex enforcement environment

Perfect for health and life sciences attorneys, compliance officers and others in the pharmaceutical and medical devices industry to stay on top of today’s challenges. Order today by calling 800.223.1940 or visiting the LexisNexis Store.