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 2018 Cumulative Supplement includes
A brand new chapter providing a comprehensive overview of pharmaceuticals reimbursement, including pharmaceuticals pricing
New medical devices sections on FDA inspection observations and letters to industry, labeling, promotional labeling, and advertising, and medical device guidance documents
A new section providing extensive charts, tables, and statistics on HIPAA enforcement activity including recovery amounts, as well as updates on privacy actions
The FDA’s Drug Competition Action Plan and efforts to expedite the review of generic drugs
Updates on the interim policy on compounding using bulk drug substances
The materiality standard as a continuing substantial threshold for potential whistleblowers under the False Claims Act
Decisions involving truth on the market and lack of materiality defenses to securities fraud cases
The 21st Century Cures Act, as well as other statutory and regulatory controls for drug development
Additional informational elements of informed consent under the revised Common Rule
U.S. Attorneys’ Manual updates on the FCPA Corporate Enforcement Policy and voluntary disclosure
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