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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

FDA Draft Guidance on Menu Labeling

USA - November 10 2017 On November 7, 2017, the Food and Drug Administration (FDA) released draft guidance regarding menu labeling requirements for certain chain restaurants…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

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USA - March 20 2017 Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air.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

Can FDA Implement The BPCIA As The CAFC Suggested?

USA - July 21 2016 In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a…