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Healthcare Hazards Involving Medical Records During Bankruptcy

USA - May 8 2018 Companies in the healthcare industry face many unique challenges when undergoing a bankruptcy, including challenges arising due to the federal and…

C.J. Donald, Jennifer S. Kreick

2017 year in review: the False Claims Act

USA - January 29 2018 The False Claims Act, 31 U.S.C. §§ 3729 et seq. (FCA), continued to be a significant focus of government and whistleblower activity in 2017. This…

Stacy Brainin, Neil Issar, Jeremy Kernodle, Taryn McDonald, Christopher Rogers, Nicole Somerville

FDAs Health Software Precertification Program Aims to Foster Innovation, Reduce Time-Cost of Market Entry

USA - November 8 2017 The American health care industry is ripe for technological disruption, but it has been slow to embrace true digital health reform. Certain government…

Neil Issar

FDA Improving Regulatory Oversight of Stem Cell Therapies and Regenerative Medicine Products

USA - November 8 2017 Regenerative medicine is a burgeoning interdisciplinary research field aiming to offer new therapies that replace or regenerate human cells, tissues…

Neil Issar

Pharmaceutical Manufacturers Still Without Clear Guidance on Appropriate Safeguards for Copayment Coupons

USA - September 6 2017 While pharmaceutical manufacturers are continuing to face scrutiny for prescription drug prices,1 they are still without clear guidance from…

Jennifer S. Kreick