Health Care & Life Sciences

Food and Drug Law

News & Publications

April 19, 2019 – In the News James Boiani Quoted in “What’s Next for the Post-Gottlieb FDA” MM&M

April 9, 2019 – Article CBD Scrutiny May Signal Broader FDA Enforcement Trend Law360

April 2019 – Article Campie and the Granston Memo in Effect AHLA Health Care Liability & Litigation Jonah D. Retzinger

April 3, 2019 – In the News Bradley Merrill Thompson Quoted in “FDA Takes First Steps Toward New Guidance for Adaptive Medical AI” MobiHealthNews

April 3, 2019 – In the News Bradley Merrill Thompson Quoted in “New AI White Paper” POLITICO Morning eHealth

April 3, 2019 – In the News Bradley Merrill Thompson Quoted in “FDA Unveils Framework for AI-Based Medical Devices” MedTech Dive

March 28, 2019 – Article Obscure FDA Device Reporting Exemptions Draw Patient and Provider Concern Health Law Advisor Blog Bonnie Scott

March 15, 2019 – In the News Gail Javitt Cited in “The Need for Weed: Why Wall Street Is Getting Hooked on Cannabis” Financial Times

March 13, 2019 – In the News Bradley Merrill Thompson Quoted in “FDA: Device Center’s Total-Life-Cycle Reorganization to Begin March 18″ Inside Health Policy

March 7, 2019 – In the News Bradley Merrill Thompson Quoted in “Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews” RAPS Regulatory Focus

March 6, 2019 – In the News Bradley Merrill Thompson Quoted in “What Does Gottlieb’s Resignation Mean for Medtech?” MedTech Dive

March 5, 2019 – In the News Bradley Merrill Thompson Quoted in “Gottlieb, Whose FDA Made Major Strides in Digital Health, Resigns as Commissioner” MobiHealthNews

March 4, 2019 – Article OIG Evaluates Remote Patient Monitoring Arrangement TechHealth Perspectives Francesca R. Ozinal

February 2019 – Article FDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices Oracle Matthew Sprankle

February 26, 2019 – Article FDA Finalizes Two Guidance Documents Regarding Regenerative Medicine Therapies Health Law Advisor Blog Jessika Tuazon

February 22, 2019 – In the News Bradley Merrill Thompson Quoted in “FDA Officials: Too Soon to Answer Device Industry Pre-Cert Questions” FDA Week

February 15, 2019 – In the News John Linehan Quoted in “Trump’s Drug Rebate Ban Faces Fraught Legal Path” Law360

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 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’s New Draft Guidance Could Hinder Applications for Digital Combination Products” MobiHealthNews

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

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

Page 1 of 34
Next