Meet The Authors
EXAMINES THE COMPLEX RELATIONSHIPS between the pharmaceutical industry and health care delivery systems, insurers, and regulators.
The new and expanded Second Edition of Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing,offers readers a comprehensive and readable text about the dynamic and complex area of pharmaceutical and medical device law in a changing health care landscape. In this unique treatise, expert authors analyze and organize legal developments affecting the expansive regulatory arena covering drug creation, production, and sales.
With the graying of the Baby Boomer generation and the financial pressures that this group’s increased health care needs have made on federal and state governments, more and more attention is directed to drug costs and the profits of pharmaceutical manufacturers. The federal government’s increased reimbursement for pharmaceutical products under Medicare Part D has created a corresponding pressure on regulators and prosecutors to ensure that providers and pharmaceutical entities do not violate any of a number of applicable statutes and agency regulations. Obtaining a solid understanding about this area of health care practice is critical for transactional attorneys, for lawyers who counsel clients about compliance considerations, and for litigators who get involved in some of these complex cases. Annual supplements to the treatise will be invaluable in tracking changes to the relevant laws and how they are interpreted by the government and the courts.
Highlights in Pharmaceutical and Medical Device Law: Regulation of Research, Development, and Marketing, Second Edition include brand-new chapters on:
The Second Edition also provides:
The 2017 Cumulative Supplement discusses:
Amendments to the Common Rule protecting human research subjects, including changes on informed consent, research with biospecimens, exemptions, and IRB criteria
New FDA guidance on off-label promotion as well as key advertising guidance on issues such as inclusion of disease information, and character-space-limited communications in social media
Updates on numerous HIPAA enforcement actions related to data breaches and disclosure of protected health information
OIG’s final rule amending existing anti-kickback safe harbors, adding new safe harbors, and clarifying the definition of remuneration under civil monetary penalties
The DOJ’s evaluation of corporate compliance programs guidelines, as well as the DOJ and SEC’s resource guide to the U.S. Foreign Corrupt Practices Act
Updates on state laws which impact Pharmacy Benefit Manager Laws
FDA guidance on pharmaceutical compounding, including bulk drug substances and “essentially copies” of commercially available drugs
FDA memoranda on communication of unapproved uses and the First Amendment, and on communication with payors and similar entities
Contrasting applications of Escobar by lower courts in false claim act action
FDA industry guidance regarding nonproprietary names of originator biologics, related biologics, and biosimilars
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