News & Publications

Article Genetic Testing Company Agrees to Pay $1.99 Million to Resolve Allegations that it Violated the False Claims Act By Billing for Tests Not Covered Under Local Coverage Determinations Health Law Advisor Blog
Article CBD “Edibles” Face Opposition from States, FDA Health Law Advisor Blog
MobiHealthNews
Article AdvaMed Updates Code of Ethics on Interactions with Health Care Professionals Health Law Advisor Blog
In the News POLITICO Morning eHealth
In the News MobiHealthNews
Article FDA Issues Draft Guidance Related to Biomarker Qualification Health Law Advisor Blog
Article FDA Issues Draft Guidance Related to Biomarker Qualification Health Law Advisor Blog
Article Law360
In the News RAPS Regulatory Focus
Article FDA Embraces Role in Managing Medical Device Cybersecurity Risk by Issuing New Guidance Health Law Advisor Blog
Article Not Business as Usual: The Government Shutdown’s Impact at FDA Health Law Advisor Blog
Article FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices Health Law Advisor Blog
In the News BrightInsight
In the News Medtech Insight Pharma Intelligence
In the News Pharma & MedTech Business Intelligence’s The Gray Sheet
Article FDA’s New Year Resolution: Breakthrough Barriers and STeP Up Device Innovation Health Law Advisor Blog
In the News InsideHealthPolicy
In the News MedTech Dive
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In the News mHealthIntelligence
In the News InsideHealthPolicy
In the News Inside Health Policy
In the News MedTech Insight Pharma Intelligence
In the News MedTech Insight Pharma Intelligence
Article FDA to Overhaul Medical Device Approval Process Health Law Advisor Blog
December 2018/January 2019In the News FDLI Update
In the News InsideHealthPolicy
Article FDA Reexamining Communication Practices with Investigational New Drug Sponsors Health Law Advisor Blog
In the News Washington Post