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Pharmaceutical Law: Regulation of Research, Development, and Marketing is the only resource available that provides expert commentary and authoritative insights into a comprehensive range of pharmaceutical law issues.
Government enforcement against perceived instance of fraud and abuse in the health care industry continues to accelerate and expand into new areas-often leading to record-breaking settlements, sometimes exceeding a billion dollars.
The 2014 Supplement offers important updates, including discussion of a Nevada jury decision in 2013 imposing $24 million in compensatory damages and $500 million in punitive damages; new sections on ERISA statute of limitations and ERISA prompt payment laws, and new case law on equitable relief under ERISA.
The 2014 Cumulative Supplement adds discussion of the following: Medicare and Medicaid reimbursement for telemedicine; HHS 2013 omnibus amendments to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules; FDA 2014 draft guidance on drug and biologic manufacturer regulatory obligations in the context of social media marketing.
The 2014 Cumulative Supplement includes: extensive new discussion of the New Drug Application process; analysis of the FDA's 2013 final guidance recommending risk-based approaches to clinical...
The 2014 Supplement includes numerous new sets of rules including the OIG's proposed regulations related to their civil monetary penalty and exclusion authorities.
Myriad potential litigation issues were introduced by the Affordable Care Act (ACA), as health plans and other managed care organizations will have to comply not only with state mandated benefits but with federally mandated benefits as well.
The Second Edition of E-Health, Privacy, and Security Law , with CD-ROM, a reformulation of Bloomberg BNA's E-Health Business and Transactional Law , offers clear guidance on the full range of today's e-health business and transactional law issues.
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