November 8, 2018 – In the News
Neil Di Spirito Quoted in “HHS Report Finds FDA Postmarket Cybersecurity Lacking, FDA Fires Back” Inside Health Policy
October 25, 2018 – Article
CMS Seeks to Revamp Medicare Part B Drug Reimbursement through Proposed International Pricing Index (IPI) Model Health Law Advisor Blog
October 25, 2018 – In the News
Alaap Shah Quoted in “FDA Cyber Guide Provides Key Testing, Documentation Updates” Inside Health Policy Daily News
October 24, 2018 – Article
The SUPPORT for Patients and Communities Act: President Trump Signs Sweeping Opioid Law Health Law Advisor Blog
October 23, 2018 – Article
CMS Unveils Proposed Rule Regarding Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products Health Law Advisor Blog
October 19, 2018 – Article
New Federal Laws Banning “Gag Clauses” in the Pharmacy Health Law Advisor Blog
October 18, 2018 – Article
FDA Addresses Allegations of “Gaming” The Generic Drug Approval Process Through The Use of Citizen Petitions Health Law Advisor Blog
October 17, 2018 – Article
FDA Releases Draft Guidances to Promote Clinical Trial Design Efficiency Health Law Advisor Blog
October 16, 2018 – Article
New Draft Guidance on Adaptive Designs for Clinical Trials Health Law Advisor Blog
October 11, 2018 – In the News
Stuart Gerson Quoted in “Drug, Device Lobbies Weigh In on Utah Device Liability Case” Inside Health Policy Daily News
October 11, 2018 – In the News
Bradley Merrill Thompson Quoted in “Top Democrats Question FDA Pre-Cert Program Safety, Statutory Authority” MedTech Dive
October 11, 2018 – In the News
Stuart Gerson Quoted in “Kavanaugh to Play Role in Drug Patent, Pharmaceutical Company Liability Cases” Inside Health Policy
October 10, 2018 – In the News
Bradley Merrill Thompson Quoted in “Elizabeth Warren, Colleagues Pen Critical Letter on FDA Pre-Cert” MobiHealthNews
October 10, 2018 – In the News
Bradley Merrill Thompson Quoted in “Senate Democrats Raise Major Concerns October 11, with FDA Software Pre-Cert Plan” Inside Health Policy Daily News
October 1, 2018 – Article
FDA Seeks Civil Monetary Penalties Measures to Enforce Compliance with ClinicalTrials.gov Requirements Health Law Advisor Blog
September 24, 2018 – In the News
Robert Wanerman Quoted in “Trump Might Pay for Some Devices Before Medicare Approval: Industry” Bloomberg News
September 14, 2018 – Article
FDA’s Dramatic Announcement of Apple’s Clearances: Is There a Level Playing Field at FDA? LinkedIn
September 14, 2018 – In the News
Bradley Merrill Thompson Discusses FDA Approval of Apple Watch ECG Monitoring Capability Multiple Publications
September 7, 2018 – Article
Commentary: Why FDA’s Software Precertification Program May Be Bad for Business MobiHealthNews
August 21, 2018 – In the News
Neil Di Spirito Featured in “Epstein Becker Green Adds FDA Specialist to Team” Life Sciences Intellectual Property Review (LSIPR)
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 13, 2018 – In the News
Bradley Merrill Thompson Quoted in “US FDA’s Software Pre-Cert Program: Is the Authority on the Books?” Medtech Insight
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
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