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
February 13, 2019 – Article
CBD “Edibles” Face Opposition from States, FDA Health Law Advisor Blog
February 8, 2019
How Many Companies Stand to Benefit from the FDA Pre-Cert Program? Fewer Than You Might Think MobiHealthNews
February 7, 2019 – Article
AdvaMed Updates Code of Ethics on Interactions with Health Care Professionals Health Law Advisor Blog
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Bradley Merrill Thompson Quoted in “FDA’s New Draft Guidance Could Hinder Applications for Digital Combination Products” MobiHealthNews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FDA Issues Draft Guidance Related to Biomarker Qualification Health Law Advisor Blog
January 30, 2019 – Article
FDA Issues Draft Guidance Related to Biomarker Qualification Health Law Advisor Blog
January 29, 2019 – Article
An Unclear Path for Microbiome-Based Products at FDA Law360
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
January 22, 2019 – Article
Not Business as Usual: The Government Shutdown’s Impact at FDA Health Law Advisor Blog
January 16, 2019 – Article
FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices Health Law Advisor Blog
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
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
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
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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