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Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

USA - March 20 2017 Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to…

FDA Draft Guidance on Menu Labeling

USA - November 10 2017 On November 7, 2017, the Food and Drug Administration (FDA) released draft guidance regarding menu labeling requirements for certain chain restaurants…

Michael D. (Mike) Flanagan

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

USA - September 7 2017 In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed…

Jayita Guhaniyogi

Health care professionals and certificates of medical necessity under FDA consent decrees

USA - April 19 2011 Hospital legal counsel and compliance officers are familiar with the legal ramifications of certifying to medical necessity in the context of Medicare, Medicaid, and other payor reimbursement rules.

Nathaniel M. Lacktman, Heidi A. Sorensen, Lawrence W Vernaglia, Judith A. Waltz

2017 Telemedicine and Digital Health Survey

USA - November 15 2017 Fueled by surging demand among patients and providers, telemedicine is spreading rapidly throughout the health care system, according to the 2017…

Monica R. Chmielewski, Nathaniel M. Lacktman, David L. Rosen