Health Care & Life Sciences

Food and Drug Law

News & Publications

February 14, 2019 – 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 Robert E. Wanerman, Charles C. Dunham, IV

February 13, 2019 – Article CBD “Edibles” Face Opposition from States, FDA Health Law Advisor Blog Megan Robertson, Gail H. Javitt

February 8, 2019 How Many Companies Stand to Benefit from the FDA Pre-Cert Program? Fewer Than You Might Think MobiHealthNews Bradley Merrill Thompson

February 7, 2019 – Article AdvaMed Updates Code of Ethics on Interactions with Health Care Professionals Health Law Advisor Blog Priya Kaulich

February 6, 2019 – In the News Bradley Merrill Thompson Quoted in “FDA Combo Products Guidance” POLITICO Morning eHealth

February 6, 2019 – In the News Bradley Merrill Thompson Quoted in “FDA’s New Draft Guidance Could Hinder Applications for Digital Combination Products” MobiHealthNews

January 30, 2019 – Article FDA Issues Draft Guidance Related to Biomarker Qualification Health Law Advisor Blog Elena M. Quattrone

January 30, 2019 – Article FDA Issues Draft Guidance Related to Biomarker Qualification Health Law Advisor Blog Elena M. Quattrone

January 29, 2019 – Article An Unclear Path for Microbiome-Based Products at FDA Law360 Gail H. Javitt

January 28, 2019 – In the News Bradley Merrill Thompson Quoted in “510(k) Modernization: FDA Floats Need to Pursue New Authority” RAPS Regulatory Focus

January 25, 2019 – Article FDA Embraces Role in Managing Medical Device Cybersecurity Risk by Issuing New Guidance Health Law Advisor Blog Brian Hedgeman, Alaap Shah

January 22, 2019 – Article Not Business as Usual: The Government Shutdown’s Impact at FDA Health Law Advisor Blog Audrey Davis

January 16, 2019 – Article FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices Health Law Advisor Blog Matthew Sprankle

January 16, 2019 – In the News Bradley Merrill Thompson Quoted in “Regulatory Uncertainty Persists Around Medical Software” BrightInsight

January 16, 2019 – In the News Bradley Merrill Thompson Featured in “Quoted,” on the FDA’s Digital Health Pre-Certification Program Medtech Insight Pharma Intelligence

January 14, 2019 – In the News Bradley Merrill Thompson Quoted in “Pre-Cert Program Will Start Off Slow with De Novo Framing, but Big Questions Remain” Pharma & MedTech Business Intelligence’s The Gray Sheet

January 10, 2019 – Article FDA’s New Year Resolution: Breakthrough Barriers and STeP Up Device Innovation Health Law Advisor Blog Ebunola Aniyikaiye

January 10, 2019 – In the News Bradley Merrill Thompson Quoted in “Experts Disagree Over Whether FDA Has Authority for PreCert” InsideHealthPolicy

January 8, 2019 – In the News Bradley Merrill Thompson Quoted in “FDA Targets De Novo Path to Shepherd Medical Software Through Pre-Cert” MedTech Dive

January 8, 2019 – In the News Bradley Merrill Thompson Quoted in “FDA Looks to De Novo Pathway Model as it Unveils Updates to Pre-Cert Program” MobiHealthNews

December 31, 2018 – In the News Bradley Merrill Thompson Quoted in “Will Telehealth and mHealth Fulfill Their Potential in 2019?” mHealthIntelligence

December 19, 2018 – In the News Bradley Merrill Thompson Quoted in “Lawyers: FDA Proposed De Novo Rule Might Discourage Developers” InsideHealthPolicy

December 18, 2018 – In the News Bradley Merrill Thompson Quoted in “Lawyer: FDA Digital Health Report Reassuring, But Short on Safety Tips” Inside Health Policy

December 17, 2018 – In the News Bradley Merrill Thompson Quoted in “US FDA Medical Software Report Rests Concerns of Increased Regulation” MedTech Insight Pharma Intelligence

December 12, 2018 – In the News Bradley Merrill Thompson Quoted in “An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain” MedTech Insight Pharma Intelligence

December 11, 2018 – Article FDA to Overhaul Medical Device Approval Process Health Law Advisor Blog Audrey Davis

December 2018/January 2019 – In the News Megan Robertson, Lauren Farruggia Featured for FDLI Presentation on FDA Software Regulation FDLI Update

December 10, 2018 – In the News James Boiani Quoted in “Lawyers: FDA’s CLIA Waiver Guidances Give Industry More Flexibility” InsideHealthPolicy

December 6, 2018 – Article FDA Reexamining Communication Practices with Investigational New Drug Sponsors Health Law Advisor Blog Brian Hedgeman

December 6, 2018 – In the News Bradley Merrill Thompson Quoted in “Apple Now Says Its Smartwatch Tech to Detect Atrial Fibrillation Is Not for Those with Atrial Fibrillation” Washington Post

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