293 matches.
- PublicationsSolving the EDDO Guidance Puzzle1 minute read
- Media CoverageJames Boiani Quoted in “Will Trump Admin. ‘Wash Its Hands’ of FDA Lab-Test Rule?”2 minute read
- PublicationsThe LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold16 minute read
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- EventsAUTM 2025 Annual Meeting: Navigating Academic Integrity in Research - Lessons Learned from Research Misconduct1 minute read
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- Media CoverageKevin Malone Featured in AHLA’s Speaking of Health Law Podcast, “Trends in Digital Therapeutics”1 minute read
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- Media CoverageMegan Robertson Quoted in “AI in Medtech Is Taking Off. Here Are 4 Trends to Watch in 2025.”2 minute read
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- Media CoverageGeorge Breen Featured in “Medtech 2025: Deregulation, Tariffs Anticipated from New US Administration”3 minute read
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- Media CoverageMegan Robertson Quoted in “FDA Wrapped: Prominent Guidance from 2024”2 minute read
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- EventsFDLI Enforcement, Litigation, and Compliance ConferenceDecember 10-11, 20241 minute read
- Media CoverageFeatured in Law360: Epstein Becker Green Adds Research Compliance Pro Elizabeth McEvoy2 minute read
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- The DEA Is Knocking at Your Door . . . Are You Prepared?
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- The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
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- FDA Releases Laboratory-Developed Tests Final Rule
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- Direct Access Laboratory Testing: Reimbursement & Compliance
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- 2023 Health Policy Outlook
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- Health Care's Past, Present, and Future
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- Entrepreneurship in Biotech: Growing Your Business
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- Firm AnnouncementsEpstein Becker Green Welcomes Seasoned Trade Secret Litigator Erik Weibust in Boston4 minute read
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- Record-Shattering Year for FCA Recoveries in Health Care
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- President Biden’s Use of the Defense Production Act
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- PublicationsRobust Health-Care M&A Volume Ends 2020, Will Continue in 20212 minute read
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- Key Considerations for Reshoring U.S. Drug Manufacturing
- EventsHealthcare Compliance Training: An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers1 minute read
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- Product Launching in the Era of COVID-19
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- Firm AnnouncementsElizabeth Scarola Named to 2020 Florida Rising Stars List5 minute read
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- PublicationsChapter 6, "Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices"2 minute read
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- Media CoverageAlaap Shah Quoted in "Can Pacemakers (and Other Medical Devices) Really Be Hacked?"2 minute read
- Firm AnnouncementsModern Healthcare Recognizes Epstein Becker Green Among Top 10 Largest Health Care Law Firms2 minute read
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- Trends in Cybersecurity of Medical Devices: Thought Leaders in Health Law Video Series
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- Media Coverage"FDA Guidance on Decision Support Software: Implications for Industry" Featured in POLITICO Morning eHealth2 minute read
- Media CoverageJames Boiani Quoted in "Life Sciences Regulation to Watch in 2018"3 minute read
- Trends in Precision Medicine: Thought Leaders in Health Law Video Series
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- Media CoverageJames Boiani Quoted in "Combo Product Appeals Low in Number, but Lengthy in Decision Time"2 minute read
- Events2017 BIO International Convention: Medical Device Regulations1 minute read
- Events2017 BIO International Convention: Coverage and Reimbursement Strategies for Biotech Products1 minute read
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- Media CoverageStuart Gerson, Bradley Merrill Thompson Quoted in "Bipartisan House Bills Take Aim at Unsafe Medical Devices"3 minute read
- Media CoverageEpstein Becker Green’s 50-State Survey of Telemental/Telebehavioral Health (2016)Cited in "ATA's Practice Guidelines Target Telestroke, Telemental Health"1 minute read
- Media CoverageJames Boiani Quoted in "Combo Products Won't Get Special Review Pathway at US FDA Anytime Soon"1 minute read
- Media CoverageJames Boiani Discusses Petitioning FDA on Combo Drug Appeals Within 60 Days2 minute read
- Media CoverageJames Boiani Quoted in "Law Firm Challenges FDA on Combination Product Appeals"2 minute read
- Media CoverageJames Boiani Quoted in "Combination Product Designations at US FDA Need Faster Appeals, Petition Says"2 minute read
- Events17th Annual Conference on Fraud and Abuse in the Sale and Marketing of Drugs, Devices, and Medical Technology: Regulatory and Legal Considerations When Using Social Media to Promote Drugs and Medical Devices1 minute read
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- Firm AnnouncementsEpstein Becker Green Attorneys Named to Law360 Editorial Advisory Boards2 minute read
- Media CoverageAmy Dow Featured in "Law360Life Sciences Editorial Advisory Board"1 minute read
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- Media CoverageJames Boiani Quoted in "Life Sciences Legislation and Regulation to Watch in 2017"1 minute read
- Trends in Digital Health: Thought Leaders in Health Law Video Series
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- Media CoverageJames Boiani Quoted in "What's Next for LDTs? FDA May Be Eyeing a New Game Plan"1 minute read
- Media CoverageJames Boiani Quoted in "Stakeholders: Codevelopment Guide Lacks Clarity on Complementary DX"1 minute read
- Media CoverageEpstein Becker Green's 50-State Survey of Telemental/Telebehavioral Health (2016)Featured in "How Teletherapy Addresses Mental Health Needs"2 minute read
- EventsACI's 2nd National Advanced Forum on Medical Liability Claims, Coverage & Risk Management: Fighting the Latest Cyber Threats to the Healthcare Industry2 minute read
- Media CoverageRobert Wanerman Quoted in "Program to Speed Medical Device Coverage Now Permanent"2 minute read
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- Media CoverageJames Boiani Quoted in "FDA Delays UDI Date for Some Devices as It Finishes Convenience Kit Guide"1 minute read
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- PublicationsUnderstanding the Food and Drug Administration's Jurisdiction Over Laboratory-Developed Tests and Divisions Between Food, Drug, and Cosmetic Act-Regulated and Clinical Laboratory Improvement Amendments of 1988-Regulated Activities3 minute read
- Media CoverageEpstein Becker Green's Telemental/Telebehavioral Health Survey Mentioned in "Telehealth: How Companies Are Managing Employees' Mental Health"2 minute read
- Media CoverageJames Boiani Quoted in "FDA's New Combo Products Pilot Distinct from Planning Office Proposals"2 minute read
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- Firm AnnouncementsModern Healthcare Again Ranks Epstein Becker Green Among Top 10 Largest Health Care Law Firms2 minute read
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- Media CoveragePatricia Wagner Quoted in "FDA Offers Guidance in Support of Sharing Device Data with Patients"1 minute read
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- EventsSeton Hall Law U.S. Healthcare Compliance Certification Program: An Overview of Federal Health Care Programs for Drug and Device Manufacturers1 minute read
- Media CoveragePatricia Wagner Quoted in "FDA Guidance on Device Data Sharing Aligns With HIPAA: Attorney"2 minute read
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- EventsFDA Regulatory Environment for Wearables, Implantables, and Other Digital Health Devices - Wearables Crash Course Webinar Series2 minute read
- Media CoverageEpstein Becker Green Survey Featured in "Telemental Health Services on Rise, but Barriers Remain"2 minute read
- Media CoverageEpstein Becker Green's Telehealth Practice Featured in "5 Factors Influencing Telemental Health"2 minute read
- Media CoverageEpstein Becker Green's Telehealth Practice Featured in "Telehealth Increasingly Used for Mental Health Care"2 minute read
- Media CoverageEpstein Becker Green's Telehealth Practice Featured in "Telemental Health Services Bridge Gaps in Care, but Regulatory Issues a Barrier"2 minute read
- Media CoverageEpstein Becker Green's Telehealth Practice Featured in "Analyzing Telemental Health: 50 States, 50 Policies"2 minute read
- Firm AnnouncementsEpstein Becker Green Releases Comprehensive 50-State Survey on Telemental Health Laws in the United States6 minute read
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