August 17, 2018 – In the News
Neil Di Spirito Featured in “Health Hires: Epstein Becker” Law360
August 16, 2018 – In the News
Bradley Merrill Thompson Quoted in “Industry Lawyer Says FDA-Proposed Device Accessory List Too Short” Inside Health Policy
August 10, 2018 – Article
CDRH’s New Post-Market Paradigm: Why the Public Should Be Worried Medtech Insight
August 2, 2018 – Client Alerts
New Gene Therapy Guidances Signal Anticipated Growth of Product Submissions by FDA Health Care & Life Sciences Client Alert
August 1, 2018 – In the News
Bradley Merrill Thompson Quoted in “Industry Balks at FDA’s Cybersecurity Plans” MedTech Dive
July 26, 2018 – In the News
Bradley Merrill Thompson Quoted in “Industry Lawyer: Pre-Cert Program Exceeds Statute, Issues Unresolved” FDA Week
July 25, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA’s Second Draft Pre-Cert Released but Real Rule-Making Needed” Healthcare IT News
July 24, 2018 – In the News
Bradley Merrill Thompson Quoted in “CDRH Faces Tight Deadline as Questions Raised on Pre-Cert Pilot Design” Regulatory Affairs Professionals Society (RAPS)
July 18, 2018 – In the News
Bradley Merrill Thompson Comments on the FDA’s Pre-Certification Program Working Model POLITICO Morning eHealth
July 2018 – In the News
James Boiani Quoted in “The Ins and Outs of Lab-Developed Tests” Lab Manager
July 12, 2018 – In the News
Stuart Gerson Quoted in “Lawyer Close to Kavanaugh Said He Avoids Knee-Jerk Deference to FDA” FDA Week
July 5, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Green-Lights 14 Digital Health Products, Continues to Evolve Regulations” MobiHealthNews
July 5, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Heads Call for Flexible Regulatory Framework for Medical Software” FDA Week
June 29, 2018 – In the News
James Boiani Quoted in “Device Lawyer: FDA Guidances Provide Clarity on Payer Communication” FDA Week
June 25, 2018 – In the News
Gail Javitt Quoted in “Three Ways ‘Right-to-Try’ Will Impact Managed Care Organizations” Managed Healthcare Executive
June 2018 – In the News
Bradley Merrill Thompson Featured in “Regulating CDS and AI: Which Way Forward?” Insights: HIMSS Europe
June 25, 2018 – Article
Cheers to 80 Years: Celebrating the Anniversary of the Federal Food, Drug, and Cosmetic Act Health Law Advisor Blog
June 22, 2018 – Article
Cheers to 80 Years of the Food, Drug, and Cosmetic Act Law360
June 20, 2018 – In the News
Bradley Merrill Thompson Discusses FDA Pre-Certification Update in Multiple Publications Multiple Publications
June 13, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Releases Draft Patient-Experience Data Guidance” Politico Morning eHealth
May 30, 2018 – In the News
Gail Javitt Discusses Implications of “Right to Try” Bill Multiple Publications
May 29, 2018 – Article
Right-to-Try Doesn’t Help Patients, Hurts FDA, Drugmakers Bloomberg Law Pharma & Life Sciences
May 23, 2018 – In the News
Amy Dow Quoted in “Congress Gives Patients the ‘Right to Try’ Experimental Drugs, Bill Heads to White House” Wolters Kluwer Health Law Daily
May 17, 2018 – In the News
Bradley Merrill Thompson Quoted in “Attorney: FDA Draft Re-Do of Part 3 Eases Agency’s Legal Burden” BioWorld
May 14, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Proposes Changes to Classification Rules for Combo Products” Regulatory Affairs Professionals Society (RAPS)
April 27, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Unveils Working Model for Software Precertification Program” Health Data Management
April 27, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Lays Out Next Steps for Pre Cert Pilot” Healthcare Dive
April 26, 2018 – In the News
Bradley Merrill Thompson Quoted in “As FDA’s Pre-Cert Plan Takes Shape, Worries Emerge About Overreach” MobiHealthNews
April 26, 2018 – In the News
Bradley Merrill Thompson Quoted in “FDA Readies Digital Health Pre-Cert Program for Lift Off” Medtech Insight
April 26, 2018 – In the News
Bradley Merrill Thompson Quoted in “Industry Attorney Says FDA’s New Device Plan Oversteps Authority” InsideHealthPolicy
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