115 matches.
- BlogsUnpacking Averages: Exploring Data on FDA’s Breakthrough Device Program Obtained Through FOIA13 minute read
- BlogsUnpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software6 minute read
- BlogsUnpacking Averages: Assessing FDA’s Postmarket Surveillance Under Section 52211 minute read
- BlogsUnpacking Averages: How Old Are Medical Devices on the US Market?5 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 202514 minute read
- BlogsUnpacking Averages: Is It Too Soon to Study the Postmarket Experience of AI-Driven Medical Devices?13 minute read
- BlogsUnpacking Averages: Intended Use Words Most Common to Devices That Require Clinical Trials8 minute read
- EventsUnpacking the Legal Challenges in Sourcing AI in Health Care and Life Sciences in the US and the EUJune 17 and 21, 202410 minute read
- BlogsUnpacking Averages: Growth of AI/ML in Medicine as Evidenced by Clinical Trials11 minute read
- EventsNew Final Regulation Prohibiting Algorithmic Discrimination by Health Care Providers and Payers2 minute read
- EventsAHLA: The Complexities of AI in Health Care1 minute read
- BlogsUnpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program11 minute read
- BlogsHHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms16 minute read
- Firm AnnouncementsFourteen Epstein Becker Green Attorneys Named to the 2024 Washington, DC, Super Lawyers and Rising Stars Lists7 minute read
- BlogsUnpacking Averages: Adverse Events for Device-Lead Combination Products7 minute read
- BlogsUnpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents14 minute read
Firm AnnouncementsThree Epstein Becker Green Attorneys Cited for Noteworthy Thought Leadership in JD Supra 2024 Readers’ Choice Awards4 minute read- BlogsUnpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not Disproportionately Hurting Minorities9 minute read
- BlogsUnpacking Averages: The Seasonality of FDA 510(k) Decision-Making and the Impact of Michigan Playing for a National Championship10 minute read
- BlogsUnpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic10 minute read
- BlogsUnpacking Averages: Sample Size for Clinical Trials Used to Obtain FDA Medical Device Clearance13 minute read
- BlogsWhite House Executive Order on Artificial Intelligence: Implications for the Health Care and Life Sciences Industries6 minute read
- BlogsUnpacking Averages: FDA’s Extraordinary Delay in Resolving Citizen Petitions17 minute read
- EventsACC NYC: Data Rights, Privacy, and Cybersecurity Issues in Contracts with AI Vendors1 minute read
- EventsACC NYC Webinar: Data Rights, Privacy and Cybersecurity Issues in Contracts with AI Vendors1 minute read
- BlogsUnpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?13 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession12 minute read
- BlogsFDA Oversight of AI Software Developed by Health Care Providers23 minute read
- BlogsUnpacking Averages: Analyzing the Relationship Between MDRs and Recalls21 minute read
- BlogsUnpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents18 minute read
- EventsAchieving Legal Compliance in AI: Minimizing Bias in Algorithms3 minute read
- BlogsUnpacking Averages: Understanding the Potential for Bias in a Sepsis Prediction Algorithm, a Case Study30 minute read
- BlogsUnpacking Averages: Success Rates for FDA FOIAs by Topic and Requester9 minute read
- Firm AnnouncementsThirteen Epstein Becker Green Attorneys Named to the 2023 Washington, DC, Super Lawyers and Rising Stars Lists4 minute read
- BlogsUnpacking Averages: FDA FOIA Response Times by Topic of Request17 minute read
- BlogsUnpacking Averages: Exploring New Data on FDA Responses to FOIA Requests14 minute read
Videos & Podcasts- BlogsUnpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development18 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in “And Over at FDA …”2 minute read
- BlogsUnpacking Averages: Creating an Industry-Specific Index to Track the FDA Regulatory Environment9 minute read
- BlogsUnpacking Averages: The Difference Between Data and the Truth: Comparing FDA’s UDI Database with FDA’s 510(k) Database9 minute read
- BlogsUnpacking Averages: Finding Medical Device Predicates Without Using FDA’s 510(k) Database5 minute read
- BlogsUnpacking Averages: Using Natural Language Processing to Extract Quality Information from MDRs9 minute read
- BlogsUnpacking Averages: Assessing FDA’s Focus on Enforcing 510(K) Requirements on Imports9 minute read
Firm AnnouncementsEpstein Becker Green Attorneys Recognized by 2023 Best Lawyers for Excellence in the Legal Profession11 minute read- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program”2 minute read
- BlogsUnpacking Averages: Assessing Whether FDA’s Breakthrough Device Designation Is Helpful10 minute read
- BlogsUnpacking Averages: Common Root Causes Driving Medical Device Recalls7 minute read
- EventsExplainable Artificial Intelligence and Transparency: Legal Risks and Remedies for the "Black Box" ProblemJune 9, 20222 minute read
- BlogsUnpacking Averages: Violations Found in Medical Device Warning Letters12 minute read
- BlogsUnpacking Averages: Device Inspection Citations That Frequently Precede Warning Letters18 minute read
- Firm AnnouncementsThirteen Attorneys Named to the 2022 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- BlogsUnpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA13 minute read
- BlogsUnpacking Averages: Connecting Published Clinical Trials with FDA Drug Approvals8 minute read
- BlogsUnpacking Averages: Assessing the Racial Composition of Drug Clinical Trial Subjects6 minute read
- BlogsUnpacking Averages: Likelihood of FDA Medical Device Inspections6 minute read
- BlogsUnpacking Averages: Popular Ways to Combine Device Functionality4 minute read
- BlogsUnpacking Averages: Analyzing Descriptions from Cardiovascular Device Adverse Events5 minute read
- BlogsUnpacking Averages: FDA Review Time for 510(k)s5 minute read
- EventsEU-US Webinar: Shaping the Future of Artificial Intelligence (AI) Within Life SciencesSeptember 30, 20212 minute read
- Firm AnnouncementsFifty-Eight Epstein Becker Green Attorneys Recognized for Professional Excellence–Three Attorneys Distinguished as “Lawyer of the Year”–by The Best Lawyers in America 20227 minute read
- EventsNIST’s Proposal on Bias in Artificial Intelligence Roundtable3 minute read
- Firm AnnouncementsTen Epstein Becker Green Attorneys Named to 2021 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- EventsBias in Artificial Intelligence: Legal Risks and Solutions3 minute read
- BlogsAI-Based Compensation Management and Bias: Can AI Close the Pay Gap?5 minute read
- BlogsExploring Intentional Bias in the Marketing of Consumer Products3 minute read
- BlogsBias in Healthcare Algorithms4 minute read
- Firm AnnouncementsFifty-Five Epstein Becker Green Attorneys Recognized for Professional Excellence–Two Attorneys Distinguished as “Lawyer of the Year”–by The Best Lawyers in America 20217 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys Named to 2020 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- Media CoverageEpstein Becker Green Analysis Featured in "Healthcare Predictions for 2020: Health Systems Will Get Bigger, Demand for Physicians Will Grow"3 minute read
- Blogs7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 20205 minute read
- Firm AnnouncementsForty-Seven Epstein Becker Green Attorneys Named by The Best Lawyers in America 2020, One Attorney Distinguished as "Lawyer of the Year"5 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys in Washington, DC, Named to 2019 Super Lawyers and Rising Stars Lists6 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Selected for The Best Lawyers in America 2019 and Four Attorneys Named "Lawyer of the Year"5 minute read
- Firm AnnouncementsSeventeen Epstein Becker Green Attorneys Named to 2018 Washington DC Super Lawyers and Rising Stars Lists5 minute read
- Media Coverage"FDA Guidance on Decision Support Software: Implications for Industry" Featured in POLITICO Morning eHealth2 minute read
- Firm Announcements38 Epstein Becker Green Attorneys Selected for The Best Lawyers in America 2018, One Honored as "Lawyer of the Year"5 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms in 2017 Edition of Chambers USA3 minute read
- Media CoverageStuart Gerson, Bradley Merrill Thompson Quoted in "Bipartisan House Bills Take Aim at Unsafe Medical Devices"3 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys Named to 2017 Washington DC Super Lawyers and Rising Stars Lists5 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 CoverageBradley Merrill Thompson, James Boiani Quoted in "Attorneys Question Usefulness of New Combo Products Pre-RFD Process"2 minute read
- Firm Announcements35 Epstein Becker Green Attorneys Selected for The Best Lawyers in America 2017, One Honored as "Lawyer of the Year"5 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
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms in 2016 Edition of Chambers USA3 minute read
- Firm Announcements58 Epstein Becker Green Attorneys Named to 2015 Super Lawyers and Rising Stars Lists7 minute read
- Media CoverageHow the FDA Process Is Biased Against New Technology2 minute read
- Firm Announcements32 Epstein Becker Green Attorneys Selected for The Best Lawyers in America 20165 minute read
- Media CoverageBradley Merrill Thompson, James Boiani Quoted in "House Committee Draft Bill Would Change Regulation of Diagnostic Tests"2 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms in 2015 Edition of Chambers USA3 minute read
- BlogsThe LDT Debate: Understanding FDA's Jurisdiction Over IVDs Made at a Clinical Lab26 minute read
- Media CoverageBradley Merrill Thompson, James A. Boiani Quoted in "GOP Senate Will Press FDA to Ease Up"2 minute read
- Firm Announcements54 Epstein Becker Green Attorneys Named to 2014 Super Lawyers and Rising Stars Lists6 minute read
- PublicationsThe Evolving US mHealth Regulatory Landscape
- Firm Announcements24 Epstein Becker Green Attorneys Selected for The Best Lawyers in America 20154 minute read
- Media CoverageBradley Merrill Thompson and James A. Boiani Mentioned in "Breaking Down the Regulation of LDTs: Moving Forward"2 minute read
- Media CoverageBradley Merrill Thompson and James Boiani Mentioned in "Breaking Down the Regulation of LDTs: Access to Innovative IVDs"2 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms in 2014 Edition of Chambers USA4 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Selected as Members of Law360's 2014 Editorial Advisory Boards2 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms in 2013 Edition of Chambers USA4 minute read
- Firm AnnouncementsSuper Lawyers 2013 Recognizes Epstein Becker Green Attorneys3 minute read
- Media CoverageAt HIMSS, Interoperability Calls Shotgun, in Medical Device and Diagnostic Industry2 minute read
- Firm AnnouncementsEpstein Becker Green Recognized for Work in Health Care Industry; Receives 2012 Chambers USA Award for Excellence in Healthcare3 minute read
- Media CoverageDavid Matyas, Bradley Merrill Thompson Quoted in Article, "Regulatory Demands to Spur Health M&A in 2012: Report"2 minute read
- Media CoverageMark Lutes Quoted in Article, "Payers Gain Influence Over the Delivery Side of Healthcare Through Acquisition Deals"1 minute read
- Media CoverageBradley Merrill Thomson Quoted in Blog About FDA Draft Guidance2 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Leading Law Firms by Chambers USA4 minute read
- PublicationsIn Vitro Diagnostics: The Complete Regulatory Guide1 minute read
- PublicationsTop Ten Key Issues Concerning "Biosimilars"13 minute read
- EventsAHLA Life Sciences Law Institute2 minute read
- PublicationsTop Ten Tips For Operating An Effective Corporate Compliance Program6 minute read
- PublicationsTop Ten Ways Health Care Reform Benefits Packages Will Affect Innovation in the Life Sciences Sector6 minute read
- Media CoverageEpstein Becker & Green Announces Launch of EBG ClinTrials Law Initiative2 minute read
- Media CoverageHealthLaw360 Profiles EBG ClinTrials Law Initiative2 minute read