164 matches.
- EventsASPL Developments in Pharmacy Law Seminar: Regulatory, Industry, and Legal Perspectives on the Future of the DSCSA3 minute read
- EventsSupplySide West: Ingredient Claims and Legal Flames - an Interactive Workshop to Dodge Regulatory Heat1 minute read
- EventsMAGI@home 2024: Collaboration Over Confrontation - CTA Negotiation Tips & Tricks1 minute read
- EventsThe REAL Summit: The Legal and Regulatory Landscape of Psychedelics - Essential Information for Investors1 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
- 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
- Firm AnnouncementsFour Epstein Becker Green Attorneys Named to the 2024 Massachusetts Super Lawyers and Rising Stars Lists8 minute read
- BlogsVideo: New State Legislation Increases Oversight of Health Care Transactions – Thought Leaders in Health Law2 minute read
New State Legislation Increases Oversight of Health Care Transactions- BlogsUnited States’ Complaint-in-Intervention Highlights Continuing Effort to Use the False Claims Act to Pursue Alleged Cybersecurity Violations5 minute read
- BlogsVideo: New HIPAA Final Rule - Key Changes to Reproductive Health Care Privacy – Thought Leaders in Health Law3 minute read
- Media CoverageRichard Hughes Quoted in “DOJ Asks SCOTUS to Reverse Braidwood Ruling, Uphold ACA’s Preventative Mandate”3 minute read
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New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy
- EventsHot Topics in Data Governance: Artificial Intelligence (AI) and Clinical Research1 minute read
- EventsRAPS Convergence: Cross-Industry Insights - Leveraging AI to Elevate NextGen Regulatory1 minute read
- Media CoverageKate Heffernan Quoted in “Colleges Get More Leeway to Handle Research Misconduct”2 minute read
- Media CoverageBBA Spotlight Series: Get to Know Emerging Leaders in Boston Law–Marylana Saadeh Helou8 minute read
- EventsNECANN: The Status and Future of the Psychedelics Industry in New Jersey and Beyond1 minute read
- Media CoverageRichard Hughes Quoted in “DOJ Will Ask SCOTUS to Take Up Braidwood”3 minute read
- BlogsUnpacking Averages: How Old Are Medical Devices on the US Market?5 minute read
- Media CoverageChristopher Smith Quoted in “HDA 2024 Traceability Seminar: A Legal Perspective Regarding DSCSA”5 minute read
- EventsHDA 2024 Traceability Seminar: Legal Perspectives for DSCSA Compliance Teams1 minute read
- EventsNACDS Total Store Expo: The DSCSA and Chain Drug Stores - Recent Developments and the Future1 minute read
- EventsNational Association of Chain Drug Stores Total Store Expo Pharmacy Compliance Roundtable1 minute read
- BlogsCMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin Supplements and More; Comments Due September 913 minute read
- BlogsRecent Supreme Court Decisions and the DSCSA15 minute read
- Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- EventsNCURA Annual Meeting: Key Challenges in Navigating Research Misconduct Proceedings2 minute read
- BlogsUnpacking Averages: Is It Too Soon to Study the Postmarket Experience of AI-Driven Medical Devices?13 minute read
- BlogsPodcast: The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care2 minute read
The DEA Is Knocking at Your Door . . . Are You Prepared?- BlogsFDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners13 minute read
- BlogsPodcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care2 minute read
- BlogsHow Does the End of Chevron Deference Change the Relationship Between the Health Care Industry, Federal Regulators, and Congress?12 minute read
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The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
- EventsAdolescent Meningococcal Vaccines: Impact and Potential Changes1 minute read
- BlogsPodcast: Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court – Diagnosing Health Care2 minute read
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Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court
- EventsPsilocybin Legalization: New York, New Jersey, Colorado1 minute read
- PublicationsFDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans16 minute read
- EventsThe Law of Psychedelics1 minute read
- BlogsThoughts: AB 3129 Expands Its Reach7 minute read
- BlogsUnpacking Averages: Intended Use Words Most Common to Devices That Require Clinical Trials8 minute read
- Media CoverageRichard Hughes Quoted in “Feds' 5th Circ. Win on Preventive Care May Imperil ACA”3 minute read
- Media CoverageRichard Hughes Quoted in “Obamacare Mandate Battle Shifts After Appeals Court Speaks”3 minute read
- EventsMultipurpose Prevention Technology (MPT) Summit: Experiences from Other Fields to Help Address MPT Roadblocks1 minute read
- Media CoverageRichard Hughes Quoted in “‘A Mixed Bag’: Fifth Circuit Rules on ACA Preventive Services Legal Case”3 minute read
- Media CoverageRichard Hughes Quoted in “Appeals Court Finds 'Obamacare' Pillar Unconstitutional in Suit Over HIV-Prevention Drug”3 minute read
- Media CoverageRichard Hughes Quoted in “Court Upholds ACA’s Free Preventive Services Mandate”3 minute read
- Media CoverageRichard Hughes Quoted in “News Briefs: Court Upholds ACA Preventive Services Coverage Mandate, for Now”2 minute read
- Media CoverageRichard Hughes Quoted in “Fifth Circuit Maintains ACA Preventive Mandate; but Remands Vaccine, Birth Control”1 minute read
- EventsBCBS Association: Legal and Regulatory Challenges in Psychedelic Research and Commercialization2 minute read
- BlogsPodcast: If Cannabis Is Reclassified, What Will Happen to the Marketplace? – Diagnosing Health Care2 minute read
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If Cannabis Is Reclassified, What Will Happen to the Marketplace?
- 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
- EventsCIRS: Vaccines for Adults – Increasing Access and Uptake1 minute read
- BlogsUnpacking Averages: Growth of AI/ML in Medicine as Evidenced by Clinical Trials12 minute read
- BlogsNuts or Not Nuts? Second Circuit Declines to Consider Whether KIND’s Use of All-Natural Is Deceptive, Misleading5 minute read
- EventsBCBS Association: The World of Emerging Therapies and Alternative Substances in Healthcare2 minute read
- BlogsLitigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast41 minute read
Litigating Nutrition: Class Action Battles Over Dietary Supplements-
FDA Releases Laboratory-Developed Tests Final Rule
- BlogsUnpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program11 minute read
- BlogsFederal Update on Cannabis Scheduling: Are State Legalized Cannabis Dispensaries to Become Pharmacies?7 minute read
- BlogsHHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms16 minute read
- 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
- PublicationsFive Commissioners and a Vote on Noncompetes to Come2 minute read
- EventsABA 2024 HIV Law & Practice Conference: HIV Healthcare – Developments and Possibilities1 minute read
- Events2024 NCICP: Legal Landscape for Vaccination1 minute read
- BlogsFDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements6 minute read
- BlogsUnpacking Averages: Adverse Events for Device-Lead Combination Products7 minute read
- BlogsLast Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future10 minute read
- EventsAPhA2024: The Inflation Reduction Act - Implications for Pharmacy2 minute read
- PublicationsFTC Continues Investigation into PBM Practices2 minute read
- EventsRx Drug Pricing Boot Camp: An In-Depth Look at the Effects of the Genesis Case1 minute read
- BlogsFDA Releases Draft Guidance on New Dietary Ingredient Notification Procedures, Timelines11 minute read
- PublicationsFDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research Participants9 minute read
- BlogsFifth Circuit Poised to Uphold Ruling Striking Down Preventive Coverage Requirement4 minute read
- BlogsMaking Moves – FDA’s LDT Proposed Rule Sent to OMB for Review2 minute read
- BlogsUnpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents14 minute read
- PublicationsWill Religious Freedom Claims Trump Public Health? Braidwood and HIV Prevention2 minute read
- Media CoverageRichard Hughes Quoted in “ObamaCare Faces Key Hearing After Texas Ruling”2 minute read
- Media CoverageRichard Hughes Quoted in “4 Argument Sessions Benefits Attys Should Watch in March”4 minute read
- Media CoverageRichard Hughes Quoted in “Affordable Care Act Preventive Services Under Threat: Previewing Braidwood Oral Arguments”4 minute read
- BlogsVideo: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law2 minute read
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Braidwood v. Becerra: Challenging the Affordable Care Act’s Preventive Services Coverage Provision
- Media CoverageRichard Hughes Quoted in “Doc Pay Patch Could Emerge in Scaled-Back Health Package; Budget Talks Continue”2 minute read
- BlogsIn Alabama, Pre-Embryos are “Extrauterine Children” Under the State’s Wrongful Death Statute11 minute read
- BlogsFDA Releases Updated Directory on Select Dietary Supplement Ingredients5 minute read
- EventsLife Sciences AI Summit: Navigating FDA and EMA Directives - Shaping AI’s Role in the Life Sciences2 minute read
- BlogsNJ Approves Cannabis Regulatory Amendment with Major Impacts on Class 5 Retail License Holders6 minute read
- BlogsUnpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not Disproportionately Hurting Minorities10 minute read
- Events340B Coalition Winter Conference 2024: Contract Pharmacy Deeper Dive1 minute read
- EventsFundamentals of Digital Health Regulation: What Advertising and Promotion Requirements Apply?1 minute read
- PublicationsEnsure Equity and Feasibility in Updating Meningococcal Vaccine Recommendations2 minute read
- PublicationsSponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement13 minute read
- BlogsUnpacking Averages: The Seasonality of FDA 510(k) Decision-Making and the Impact of Michigan Playing for a National Championship10 minute read
- EventsNJSBA: Dietary Supplement Litigation - Nutraceuticals and the Law3 minute read
- BlogsUnpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic10 minute read
- EventsPRIM&R Annual Conference: Ethical, Legal, and Regulatory Challenges of Conducting Research on Psychedelic Substances1 minute read
- EventsImplications of the Genesis Federal Court Decision on 340B Patient Definition2 minute read
- EventsWorld Vaccine Congress West Coast: How Are NITAGs & HTAs Thinking About Novel Antibody Products?1 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
- EventsBBA: New Rules to Research Misconduct? How the Office of Research Integrity’s Proposed Revisions to PHS Rules on Research Misconduct May Affect You2 minute read
- BlogsUnpacking Averages: Sample Size for Clinical Trials Used to Obtain FDA Medical Device Clearance13 minute read
- EventsASPL Developments in Pharmacy Law Seminar: Drug Supply Chain Security Act Changes and Implications for Dispensers2 minute read
- BlogsFDA LDT Webinar Serves as a Reminder to Industry to Submit Comments on the Proposed Rule3 minute read
- BlogsWhite House Executive Order on Artificial Intelligence: Implications for the Health Care and Life Sciences Industries6 minute read
- PublicationsCMS Seeks Stakeholder Feedback About Medicare Transaction Facilitator Services for the Medicare Drug Price Negotiation Program by November 13: Inflation Reduction Act Updates4 minute read
- EventsPharmaceutical and Medical Device Ethics and Compliance Congress: Drug Pricing—Considerations Around Price Controls, Negotiation, and Access1 minute read
- EventsFDA's LDT Proposed Rule: A Discussion1 minute read
- PublicationsNavigating the Medtech GenAI Journey: A Policy Primer2 minute read
- BlogsCongress May Have a Vision for Psychedelic Regulation in the US5 minute read
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Game-Changing IRA: Revolutionizing Prescription Drug Pricing and Medicare Benefits
- PublicationsORI Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct7 minute read
- EventsACC NYC Webinar: Data Rights, Privacy and Cybersecurity Issues in Contracts with AI Vendors1 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
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Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
- PublicationsA Topic-Based Analysis of FDA Responses to FOIA Requests1 minute read
- EventsThe Creation and Use of Trustworthy AI Tools in Health Care and Beyond: Laws and Enterprise Risk Management Techniques3 minute read
- BlogsUnpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?13 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
Firm AnnouncementsEpstein Becker Green Receives New York Law Journal’s 2023 Innovation Award4 minute read-
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now?
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory Framework26 minute read
- Events11th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements: Class Action Boot Camp2 minute read
- EventsAchieving Legal Compliance in AI: Minimizing Bias in Algorithms3 minute read
- EventsWhat's Nyoo! 30 Years of Women in Clinical Research - What It Means for You2 minute read
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Post-Dobbs: One Year Later
- PublicationsCMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates7 minute read
- PublicationsManufacturers Must Request Small Biotech Exception by July 3: Inflation Reduction Act Updates4 minute read
- EventsHealth Law Professors Conference: Tying Health Outcomes to Legal Doctrines - the Pedagogical Value of Teaching Vaccine Law1 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
- PublicationsCMS Seeks Comment on Initial Guidance for the Part D Manufacturer Discount Program: Inflation Reduction Act Updates2 minute read
- EventsMedicaid and Government Pricing Congress2 minute read
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The Legal Battle Over Mifepristone
- EventsRx Drug Pricing Boot Camp: A Look into the Seismic Impact of Litigation on the 340B Drug Pricing Program1 minute read
- PublicationsCMS Issues an Information Collection Request for the Drug Price Negotiation Process: Inflation Reduction Act Updates3 minute read
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Direct Access Laboratory Testing: Physician Orders and Specimen Collection
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Legal and Regulatory Landscape for Psychedelics as Therapies
- PublicationsCMS Issues an Information Collection Request on Negotiation Data Elements: Inflation Reduction Act Updates3 minute read
- PublicationsCMS Issues New Guidance on Medicare Drug Price Negotiation Program: Inflation Reduction Act Updates2 minute read
- PublicationsCMS Releases Its List of 27 Part B Rebatable Drugs for Q2 of 2023: Inflation Reduction Act Updates3 minute read
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Direct Access Laboratory Testing: Reimbursement & Compliance
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Direct Access Laboratory Testing: Navigating the Regulatory Landscape
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Unpacking FDA's Final Clinical Decision Support Guidance
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Post-Dobbs: Considerations for Clinical Trials and Research
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Post-Dobbs: Access to Reproductive Health Care and Abortion-Inducing Drugs
Firm AnnouncementsEpstein Becker Green Announces 2023 PromotionsOctober 28, 20225 minute read- EventsNACDS: Pharmacy Compliance with the Drug Supply Chain and Security ActOctober 12, 20221 minute read
- Firm AnnouncementsEpstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law2 minute read
- PublicationsOHRP Draft Guidance on the Use of Single IRBs: Reminder to Comment by August 308 minute read
- EventsTech Briefs: Artificial Intelligence and Machine Learning—Making Medical Devices SmarterAugust 25, 20222 minute read
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Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act
- 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
- EventsExplainable Artificial Intelligence and Transparency: Legal Risks and Remedies for the "Black Box" ProblemJune 9, 20222 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2022 Southern California Rising Stars List5 minute read
- Media CoverageJenny Nelson Carney Quoted in “Arena District Lands Local Offices for Two Out-of-State Firms”2 minute read
- EventsMicrofluidics to Address Pandemics - SARS-CoV-2 and Beyond2 minute read
