311 matches.
- EventsFDLI Enforcement, Litigation, and Compliance: Supplement Scene 2025 - Enforcement, Litigation, and Labeling Regulations2 minute read
- EventsFDLI Enforcement, Litigation, and Compliance: From States to FDA—Understanding the New Wave of Medical Device Enforcement1 minute read
- EventsGMMDC: The Impact of Geopolitical Issues on MedTech1 minute read
- PublicationsMegan Robertson Answers: How Does the Loper Decision Reshape FDA's Authority Over Lab Tests?3 minute read
- Media CoverageMartin Monaco, John Barry Featured in “On the Move: Epstein Becker Green”2 minute read
- BlogsVendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion6 minute read
- Firm AnnouncementsEpstein Becker Green Expands Health Care Corporate and Transactional Team with Martin L. Monaco, Jr., and John D. Barry in New Jersey3 minute read
- BlogsNew OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device5 minute read
- Media CoverageMarylana Helou Quoted in “HHS Devises Legal Playbook for Future Grant Terminations, Internal Memo Shows”2 minute read
- Media CoverageLisa Pierce Reisz Quoted in “Wearables Take Center Stage in RFK Jr.’s Personal Health Push”3 minute read
- Media CoverageMegan Robertson Quoted in “FDA's Makary Breaks Open 'Black Box' On New Podcast”1 minute read
- BlogsOIG Says Medical Device Company's Proposal to Pay for Exclusion Screening for Customers May Violate the Anti-Kickback Statute5 minute read
- BlogsA Final Rule Bites the Dust, Part II: FDA Gives up on Regulating LDTs as Medical Devices4 minute read
- PublicationsThe Final Rule on Research Misconduct Regulations: What Institutions Need to Know as Implementation Looms24 minute read
- EventsNCLifeSci: Regulatory Landscape: Changes at the FDA and Impacts on Devices and Drugs1 minute read
- BlogsVideo: Federal Court Strikes Down FDA Rule on LDTs – Thought Leaders in Health Law2 minute read
Videos & Podcasts- 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
- BlogsA Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs2 minute read
- Media CoverageMegan Robertson Quoted in “5 Tips for Building a Predetermined Change Control Plan”3 minute read
- EventsAUTM 2025 Annual Meeting: Navigating Academic Integrity in Research - Lessons Learned from Research Misconduct1 minute read
- Media CoverageMegan Robertson Quoted in “Loper Bright No Free Pass Where FDA’s LDT Rule Is Concerned”2 minute read
- EventsFDLI Digital Health Technology and Regulation: The Next-Gen Regulatory Arena1 minute read
- Media CoverageKevin Malone Featured in AHLA’s Speaking of Health Law Podcast, “Trends in Digital Therapeutics”1 minute read
- PublicationsEmbrace the Chaos: AI Regulation in the US Remains in Flux2 minute read
- Media CoverageLynn Shapiro Snyder, Rachel Snyder Good Featured in “Fireside Chat: AI in Healthcare - a Legal & Compliance Perspective”2 minute read
- EventsAHLA: The Complexities of AI in Health Care3 minute read
- Media CoverageMegan Robertson Quoted in “AI in Medtech Is Taking Off. Here Are 4 Trends to Watch in 2025.”2 minute read
- Media CoverageFlourish: Breaking Healthcare’s Glass Ceiling – a Legal Pioneer’s Journey, with Lynn Shapiro Snyder2 minute read
- Media CoverageGeorge Breen Featured in “Medtech 2025: Deregulation, Tariffs Anticipated from New US Administration”3 minute read
- Media CoverageGeorge Breen Featured in “Medtech 2025: ‘Moving Forward, No Matter What’”3 minute read
- Media CoverageMegan Robertson Quoted in “FDA Wrapped: Prominent Guidance from 2024”2 minute read
- BlogsUnpacking Averages: Exploring Data on FDA’s Breakthrough Device Program Obtained Through FOIA13 minute read
- 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
- Firm AnnouncementsEpstein Becker Green Welcomes High-Stakes Research Misconduct Attorney and Litigator Elizabeth J. McEvoy, Improves Bench Amid Federal Enforcement Surge3 minute read
- BlogsUnpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software6 minute read
- Media CoverageLisa Pierce Reisz Quoted in “New Health Apps May Pose Challenges to Patient Privacy”3 minute read
- EventsDiabetes Technology Meeting: Who Can Sell Your Data - a United States Perspective1 minute read
- EventsCombination Products Summit: Regulatory and Technical Considerations for On-Body Delivery Systems (OBDS)1 minute read
- Media CoverageMarylana Saadeh Helou Quoted in “FDA Offers Road Map for Remote Trials, but Questions Linger”2 minute read
- BlogsUnpacking Averages: Assessing FDA’s Postmarket Surveillance Under Section 52211 minute read
- EventsBreaking Barriers Toward Inclusive Health Care: New ADA Title II Regulations Require Accessible Medical Diagnostic Equipment2 minute read
- Media CoverageBBA Spotlight Series: Get to Know Emerging Leaders in Boston Law–Marylana Saadeh Helou8 minute read
- BlogsUnpacking Averages: How Old Are Medical Devices on the US Market?5 minute read
- Media CoverageDavid Shillcutt Quoted in “Proposed Digital Therapy Codes Good Idea with Barriers: Experts”2 minute read
- Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- BlogsPodcast: The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care2 minute read
Videos & Podcasts- BlogsPodcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care2 minute read
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Videos & Podcasts
- PublicationsFDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans15 minute read
- BlogsUnpacking Averages: Intended Use Words Most Common to Devices That Require Clinical Trials8 minute read
- Firm AnnouncementsElizabeth Scarola Named to the 2024 Florida Rising Stars List7 minute read
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Videos & Podcasts
- BlogsIt’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived8 minute read
- Media CoverageKate Heffernan Featured in AHLA’s Speaking of Health Law Podcast, “Trends Related to Research Misconduct”1 minute read
- Media CoverageCSHA Members Join Epstein Becker Green1 minute read
- Media CoverageRaja Sékaran, John Puente, Melissa Borrelli Featured in “Wake Up Call: Laterals, Moves, In-House”1 minute read
- Media CoverageEpstein Becker Green Grows Health Care & Life Sciences Practice2 minute read
- Media CoverageEpstein Becker Green Adds 6-Atty Healthcare Team in San Francisco2 minute read
- Media CoverageEpstein Becker Green’s Bay Area Healthcare Attorney Additions Featured in the San Francisco Business Times1 minute read
- Firm AnnouncementsEpstein Becker Green Fuels West Coast Momentum with Six-Attorney Health Care Team6 minute read
- BlogsUnpacking Averages: Adverse Events for Device-Lead Combination Products7 minute read
- PublicationsFDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research Participants9 minute read
- BlogsMaking Moves – FDA’s LDT Proposed Rule Sent to OMB for Review2 minute read
- EventsLife Sciences AI Summit: Navigating FDA and EMA Directives - Shaping AI’s Role in the Life Sciences2 minute read
- EventsAHLA: Advising Providers – Legal Strategies for AMCs, Physicians, and HospitalsFebruary 5–7, 20242 minute read
- Media CoverageMegan Robertson Quoted in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule”2 minute read
- Media CoverageAlaap Shah Quoted in “Don’t Worry, You (Probably) Won’t Have to Deal with ONC: Algorithm Transparency Rule May Have Surprise Effects on Medtech Firms”2 minute read
- BlogsUnpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic10 minute read
- BlogsSharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance14 minute read
- EventsFDA's LDT Proposed Rule: A Discussion1 minute read
- PublicationsORI Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct7 minute read
- BlogsUnpacking Averages: FDA’s Extraordinary Delay in Resolving Citizen Petitions17 minute read
- Media CoverageJames Boiani Quoted in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation”5 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- Media CoverageJames Boiani Quoted in “FDA Wants Oversight of Lab-Developed Tests”2 minute read
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Videos & Podcasts
- Media CoverageJames Boiani Quoted in “NY State Database Offers Glimpse into Laboratory-Developed Testing Landscape”3 minute read
- Media CoverageJames Boiani Quoted in “FDA Moves to Modernize Medical Devices Premarket Program”3 minute read
- PublicationsState Regulation of Pharmacy Benefit Managers: Tenth Circuit Holds That ERISA and Medicare Part D Preempt Key Parts of Oklahoma PBM Law25 minute read
- EventsWhat Should Executives Know About Artificial Intelligence?2 minute read
- Media CoverageEpstein Becker Green Update Cited in “Physicians Could Be in Financial Danger with This Stark Law Change”2 minute read
- Media CoverageBonnie Odom Quoted in “Health Care’s AI Embrace Boosts Workforce Despite Privacy Risks”2 minute read
- BlogsUnpacking Averages: Analyzing the Relationship Between MDRs and Recalls21 minute read
- BlogsTAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year27 minute read
- PublicationsEuropean Commission Adopts an Adequacy Decision for a New EU-U.S. Data Privacy Framework6 minute read
- Media CoverageRachel Snyder Good Featured in “The Top Mid-Law People Moves of 2023 So Far”2 minute read
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory Framework26 minute read
- Firm AnnouncementsElizabeth Scarola Named to the 2023 Florida Rising Stars List6 minute read
- Media CoverageHemant Gupta, Jeff McGoff Featured in “Epstein Becker Grows Health Care Practice in Dallas, Memphis”3 minute read
- Media CoverageHemant Gupta, W. Jeff McGoff Featured in “Wake Up Call: Laterals, Moves, In-House”1 minute read
Firm AnnouncementsEpstein Becker Green Adds Health Care Transactional, Technology & IP Attorneys in Memphis and Dallas Amid Ongoing Expansion4 minute read- Media CoverageAlaap Shah Quoted in "New Health App Rule Would Better Protect Users – and So Can You"2 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2023 Southern California Rising Stars List6 minute read
- PublicationsFDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials20 minute read
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Videos & Podcasts
- Firm AnnouncementsEpstein Becker Green Recognized Among Top 10 Largest Health Care Law Firms by Modern Healthcare2 minute read
- PublicationsDOJ’s Antitrust Division Continues Its Pursuit of Overlapping Directorates2 minute read
- Media CoverageRachel Snyder Good Featured in Law360 Pulse2 minute read
- Firm AnnouncementsRachel Snyder Good, Health Care Attorney, Former Advisor to U.S. House of Representatives Majority Leader Steny H. Hoyer, Joins Epstein Becker Green3 minute read
- Media CoverageJames Boiani Quoted in “FDA Resumes Move to Regulate LDTs, Likely Setting Up Legal Battle with Lab Industry”3 minute read
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Videos & Podcasts
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Videos & Podcasts
- PublicationsCongress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs14 minute read
- PublicationsRecap: Top 10 Antitrust Issues in 20222 minute read
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Videos & Podcasts
Videos & Podcasts- EventsTrade Secrets, Restrictive Covenants, and No-Poach Agreements in Health Care2 minute read
- Media CoverageElizabeth Scarola Featured in “People on the Move”1 minute read
Firm AnnouncementsEpstein Becker Green Announces 2023 PromotionsOctober 28, 20225 minute read-
Videos & Podcasts
- EventsZeroTo510: ComplianceOctober 12, 20221 minute read
- PublicationsIn Vitro Diagnostic (IVD) Devices2 minute read
- Media CoverageRichard Hughes Featured in Washington Lawyer’s “On the Move”1 minute read
- PublicationsThe Inflation Reduction Act Will Help the U.S. Achieve Maximum Vaccine Access and Uptake, but Access Gaps Remain3 minute read
- EventsNational Vaccine Law Conference 2022September 15-16, 20222 minute read
- Firm AnnouncementsEpstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law2 minute read
- Media CoverageErik Weibust Featured in “Class Notes: 2005”2 minute read
- PublicationsOHRP Draft Guidance on the Use of Single IRBs: Reminder to Comment by August 308 minute read
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Videos & Podcasts
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program”2 minute read
- PublicationsOn First Anniversary of Executive Order on Competition, DOJ Celebrates Interagency Efforts to Promote Competitive MarketsJune 28, 20222 minute read
- EventsNWABR Hybrid IRB Conference: Privacy Pile-Up—Making Sense of Multiple Frameworks for Research Participant Privacy and Data ProtectionJuly 28, 20221 minute read
- Firm AnnouncementsLynn Shapiro Snyder Serves on the Nashville Health Care Council’s Board of Directors2 minute read
- Media CoverageLynn Shapiro Snyder Continues Service on Nashville Health Care Council’s Board of Directors2 minute read
- Media CoverageRichard Hughes Featured in “Class Notes”2 minute read
- Firm AnnouncementsElizabeth Scarola Named to the 2022 Florida Rising Stars List6 minute read
Videos & Podcasts- Media CoverageRichard Hughes Featured in “Industry Moves”1 minute read
- Media CoverageRichard Hughes Featured in “Laterals, Moves, In-House”1 minute read
- Media CoverageRichard Hughes Featured in “Ex-Moderna Public Policy VP Rejoins Epstein Becker”3 minute read
- Firm AnnouncementsAttorney and Biopharma Strategist Richard Hughes Returns to Epstein Becker Green in Washington, DC4 minute read
- PublicationsConstitutionality of FTC’s Structure and Procedures Under SCOTUS Review2 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2022 Southern California Rising Stars List5 minute read
- PublicationsFinal Listening Forum on Firsthand Effects of Mergers and Acquisitions to Be Held on May 12, 20222 minute read
- Firm AnnouncementsEpstein Becker Green’s Theodora McCormick Recognized as a Trailblazing Change-Maker by the Executive Women of New Jersey4 minute read
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Firm AnnouncementsEpstein Becker Green Again Recognized as One of the Largest Health Care Law Firms2 minute read
Firm AnnouncementsEpstein Becker Green’s Managing Director James P. Flynn Named a “Leader in Law”4 minute read- PublicationsWhat Happens When Parties Abandon a Transaction Challenged by the FTC?April 21, 20222 minute read
- EventsABA: FemTech Revolution—Technology Innovation to Address Gaps in Women's HealthApril 28, 20221 minute read
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Videos & Podcasts
- Media CoverageErik Weibust Featured in “Hub Hires”2 minute read
- Media CoverageErik Weibust Featured in “IP Hires”2 minute read
- PublicationsDeconstructing Genus Medical Technologies, LLC v. FDA: A Misunderstood Court Decision16 minute read
- Media CoverageErik Weibust Featured in “Wake Up Call: Laterals, Moves, In-House”1 minute read
- Media CoverageErik Weibust Featured in “Epstein Becker Hires Trade Secret Litigator in Boston”3 minute read
- Firm AnnouncementsEpstein Becker Green Welcomes Seasoned Trade Secret Litigator Erik Weibust in Boston4 minute read
- PublicationsFTC and DOJ to Hold Listening Forums on Merger Experience2 minute read
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Videos & Podcasts
- PublicationsFDA Releases Proposed Rule on National Standards for Drug Wholesaler Licensure18 minute read
- EventsMicrofluidics to Address Pandemics - SARS-CoV-2 and Beyond2 minute read
- PublicationsRecord Number of Health-Care Deals Close 2021 with a Bang4 minute read
- PublicationsFTC and DOJ Seek Public Comments on Merger Guidelines2 minute read
- PublicationsRecap: Top 10 Antitrust Issues in 20212 minute read
- PublicationsThe $2 Trillion Build Back Better Act Passes the House, Bringing the Potential for a Significant Health Care Expansion4 minute read
- Media CoverageZachary Taylor Quoted in “Health-Care Deals on Record Pace to Hit 3,000 by Year’s End”3 minute read
- PublicationsVolume of Health-Care Deals Remains at Record Pace for 20212 minute read
- Media CoverageEpstein Becker Green Insight on CMS Proposal to Repeal Medicare Coverage of Breakthrough Devices Featured in Orthopedics This Week3 minute read
- BlogsUnpacking Averages: Analyzing Descriptions from Cardiovascular Device Adverse Events5 minute read
- PublicationsMedical Device Manufacturers, Beware: FTC Ramps Up Enforcement Against Repair RestrictionsAugust 26, 20212 minute read
- PublicationsRevisions to the PhRMA Code on Interactions with Health Care Professionals9 minute read
- EventsMachine Learning in Healthcare: Regulatory Requirements, Reimbursement Challenges, Privacy, and Security Risks2 minute read
- PublicationsHealth IT, Software Deals Lead Industry Moves So Far in 20212 minute read
- Media CoverageJames Boiani Quoted in “FDA Class I Medical Device Recalls on Track to Break Record in 2021”3 minute read
- Firm AnnouncementsElizabeth Scarola Named to 2021 Florida Rising Stars List6 minute read
- Media CoverageLynn Shapiro Snyder Joins Nashville Health Care Council’s Board of Directors2 minute read
- PublicationsRansomware: A Guide to Practical, Regulatory, and Reputational Risk Management16 minute read
- PublicationsHealth-Care M&A Deals in Q1 Set Record Pace as Economy Recovers2 minute read
- PublicationsDistinguishable Products and Tying Claims in Health Care Markets3 minute read
- Firm AnnouncementsModern Healthcare Ranks Epstein Becker Green as One of the Nation’s Largest Health Care Law Firms2 minute read
- PublicationsFTC Annual Review Shows Focus on Health Care2 minute read
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Videos & Podcasts
- EventsBias in Artificial Intelligence: Legal Risks and Solutions3 minute read
- EventsOppenheimer 31st Annual Healthcare Conference1 minute read
- Media CoverageLynn Shapiro Snyder Discusses 10 Best Practices for Advancing Women in Business on Inspiring Women5 minute read
- Media CoverageBob Hearn Featured in Law360 Pulse Article on Recent Health Care Litigator Hires in Florida2 minute read
- Media CoverageBob Hearn Featured in “Epstein Becker Adds Health Care Atty from Phelps Dunbar”3 minute read
- Firm AnnouncementsHealth Care Attorney & Commercial Litigator Robert R. Hearn Joins Epstein Becker Green3 minute read
- Media CoverageJames Boiani Quoted in “Regulatory Attorney Says Warning Letters Likely to Spike Under New FDA Administration”3 minute read
- PublicationsRobust Health-Care M&A Volume Ends 2020, Will Continue in 20212 minute read
- EventsFDLI Enforcement, Litigation, and Compliance Conference: FTC and SEC Litigation, Enforcement, and Application to FDA Authorities1 minute read
- Events2020 Advancing Ethical Research Conference: Complex Conflict of Interest - Understanding the COI Landscape2 minute read
- PublicationsUSA: HIPAA and Wearable Technology – Does It Provide a Loophole?2 minute read
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Videos & Podcasts
- EventsGCMI Virtual Experiential Learning Program: Reimbursement Pathways1 minute read
- PublicationsHealth-Care M&A Deals in Q3 Impacted by Covid-19; Election Could Shape Q43 minute read
- Firm AnnouncementsDavid S. Poppick, Peter M. Stein Named to 2020 Connecticut Super Lawyers List, Marylana Saadeh Helou Named to 2020 Massachusetts Rising Stars List7 minute read
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Videos & Podcasts
- EventsHealthcare Compliance Training: An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers1 minute read
- Media CoverageEpstein Becker Green’s Latest Health Hires in Boston Featured in Law3602 minute read
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Videos & Podcasts
- PublicationsEpstein Becker Green’s Boston Health Care and Life Sciences Practice Featured in “Hire Up: This Week’s Lateral Market”2 minute read
- Firm AnnouncementsEpstein Becker Green Adds Group of Health Care & Life Sciences Attorneys in Boston6 minute read
- PublicationsCMS Proposes to Expand the Scope of Medicare Coverage Determinations9 minute read
- Firm AnnouncementsEpstein Becker Green's Paul Gilbert Becomes General Counsel and Corporate Secretary at Rite Aid4 minute read
- EventsZeroTo510: Reimbursement – Medical Device Accelerator1 minute read
- Firm AnnouncementsEpstein Becker Green Ranks Highly as One of the Largest Health Care Law Firms by Modern Healthcare2 minute read
- Media CoverageZachary Taylor Quoted in "Health-Care Deals in May Relatively Strong Despite Pandemic"4 minute read
- Firm AnnouncementsElizabeth Scarola Named to 2020 Florida Rising Stars List5 minute read
- PublicationsINSIGHT: Health-Care Transactions Will Pick Back Up After Virus3 minute read
- Media CoverageJames Boiani Quoted in "Startups Spar with FDA Over What Constitutes a Home Coronavirus Test"3 minute read
- PublicationsINSIGHT: Fake Cures and Test Kits—Scammers Target Health Care4 minute read
- PublicationsThe CARES Act: Key Provisions for Health Care Providers7 minute read
- PublicationsAntitrust Law Compliance During Public Health Emergencies2 minute read
- PublicationsFDA and FTC Join Forces to Promote Biosimilars3 minute read
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Videos & Podcasts
- Media CoverageEpstein Becker Green Analysis Featured in "Healthcare Predictions for 2020: Health Systems Will Get Bigger, Demand for Physicians Will Grow"3 minute read
- PublicationsChapter 6, "Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices"2 minute read
- Media CoverageJulie Watson Lampley, Machelle Dunavant Shields Featured in "Legal Briefs – EBG Adds to Nashville Healthcare Practice"2 minute read
- Media CoverageJulie Watson Lampley Featured in "Laterals, Moves"1 minute read
- Media CoverageJulie Watson Lampley Featured in Law360's Roundup of Health Hires2 minute read
- Media CoverageJulie Watson Lampley, Machelle Dunavant Shields Featured in "Prominent Law Firm Loses Nashville Chief"2 minute read
- Media CoverageJulie Watson Lampley, Machelle Dunavant Shields Featured in "National Firm Adds to Tennessee Health Care Team"2 minute read
- Firm AnnouncementsEpstein Becker Green Grows Tennessee Presence with Experienced Health Care Hires4 minute read
- 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
- Media CoverageJames Boiani Quoted in "At-Home Tests for Influenza, Strep, Others Raising Eyebrows of Some Experts"2 minute read
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Videos & Podcasts
- EventsRetail and Specialty Pharmacy: Strategic and Regulatory Considerations for Expanding Hospital Pharmacy Options1 minute read
- Media CoverageRobert Wanerman Quoted in "CMS Floats New Add-On Payment Route for Breakthrough Devices"2 minute read
- EventsOppenheimer Healthcare Investor Conference: 2019 Healthcare Outlook – Key Legal, Legislative, and Regulatory Issues and Trends1 minute read
- PublicationsFDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices1 minute read
- Media CoverageAlaap Shah Quoted in "After a Busy Month in Cyber, HHS Rebrands Its Cybersecurity Center"3 minute read
- Media CoverageAlaap Shah Quoted in "FDA Cyber Guide Provides Key Testing, Documentation Updates"3 minute read
- Media CoverageStuart Gerson Quoted in "Drug, Device Lobbies Weigh In on Utah Device Liability Case"1 minute read
- EventsFood and Drug Law Institute: Developments in FDA Software Regulation1 minute read
- Media CoverageRobert Wanerman Quoted in "Trump Might Pay for Some Devices Before Medicare Approval: Industry"3 minute read
- Media CoverageJames Boiani Quoted in "Device Lawyer: FDA Guidances Provide Clarity on Payer Communication"2 minute read
- PublicationsCheers to 80 Years of the Food, Drug, and Cosmetic Act1 minute read
- EventsSeton Hall Law: U.S. Healthcare Compliance Certification Program - An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers1 minute read
- EventsFDLI: Introduction to US Medical Device Law and Regulation - Overview of Medical Device Law and Regulation Organizational Structures1 minute read
- Media CoverageJames Boiani Quoted in "Nicotine Replacement Trials and the App Effect"3 minute read
- PublicationsDurable Medical Equipment1 minute read
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Videos & Podcasts
- Firm AnnouncementsEpstein Becker Green Named a 2017 "Health Practice Group of the Year" by Law3602 minute read
- 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
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Videos & Podcasts
- PublicationsThe "New" NDC: Are You Aware of FDA's Rollout of the New Unique Medical Device Identifier (UDI) and Its Potential Future Impact on Payer Claims Forms?2 minute read
- EventsThe Criminalization of Health Care: White-Collar Crash Course Webinar Series3 minute read
- Media CoverageJames Boiani Quoted in "FDA Final Guidance on Drug/Device Classifications Misses the Mark, Attorneys Say"2 minute read
- EventsWhat Are the Risks? Business Types Facing Increased Scrutiny: White-Collar Crash Course Webinar Series2 minute read
- Events"To Be a Legal Opinion or Not to Be a Legal Opinion?" That Is the In-House Communication Question: White-Collar Crash Course Webinar Series2 minute read
- EventsAMDM 2017 Focus Meeting: CLIA Waiver Updates1 minute read
- EventsThe Current Enforcement Environment: White-Collar Crash Course Webinar Series3 minute read
- EventsFDLI Advertising and Promotion Conference: Risk Information in Direct-to-Consumer Broadcast Advertisements for Prescription Drugs1 minute read
- EventsMedical Device Usability and Human Factors Engineering Conference: FDA Oversight of Human Factors Engineering for Combination Products1 minute read
- 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
- Media CoverageJames Boiani Quoted in "FDA Takes Steps Toward Creating Lab Accreditation System for Evaluating Medical Devices"2 minute read
- 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
- Events17th Annual Conference on Fraud and Abuse in the Sale and Marketing of Drugs, Devices, and Medical Technology: Not So Safe - Exploring the Boundaries of the Discount Safe Harbor in Light of Recent Court Decisions1 minute read
- 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
- PublicationsThe Legal Environment for Precision Medicine1 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in "Trump's Two-for-One Reg Order Needs Agency Interpretation, Medtech Reg Experts Say"2 minute read
- Media CoverageJames Boiani Quoted in "Life Sciences Legislation and Regulation to Watch in 2017"1 minute read
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Videos & Podcasts
- Media CoverageRobert Wanerman Quoted in "Doctors Argue Leadless Pacemakers Deserve Broader Medicare Coverage"1 minute read
- 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
- EventsHarvard T.H. Chan School of Public Health: Health Care and the Elections1 minute read
- Events2016 SupplySide West Conference: Developing and Substantiating Product Claims1 minute read
- Media CoverageJames Boiani Quoted in "FDA Delays UDI Date for Some Devices as It Finishes Convenience Kit Guide"1 minute read
- Media CoverageBradley Merrill Thompson, James Boiani Quoted in "Attorneys Question Usefulness of New Combo Products Pre-RFD Process"2 minute read
- 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
- Media CoverageJames Boiani Quoted in "FDA IVD Codevelopment Guide Seen as Step Toward Consistent Reviews"2 minute read
- PublicationsNext-Generation Sequencing: FDA Issues New Guidance for Genetic Tests15 minute read
- Media CoverageEpstein Becker Green Survey Featured in "Telemental Health Is Trending Upward"2 minute read
- Media CoverageEpstein Becker Green 50-State Survey of Telemental/Telebehavioral Health (2016) Mentioned in Fierce Healthcare1 minute read
- Firm AnnouncementsModern Healthcare Again Ranks Epstein Becker Green Among Top 10 Largest Health Care Law Firms2 minute read
- EventsPrivacy and Wearables - Wearables Crash Course Webinar Series2 minute read
- Media CoveragePatricia Wagner Quoted in "FDA Offers Guidance in Support of Sharing Device Data with Patients"1 minute read
- PublicationsThe State of Telemental Health Care2 minute read
- PublicationsPatricia Wagner Quoted in "FDA Issues Draft Guidance on Sharing Medical Device Data with Patients"1 minute read
- 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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