66 matches.
- 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
- 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
- BlogsCongress May Have a Vision for Psychedelic Regulation in the US5 minute read
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
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
- EventsAmerican Conference Institute 41st FDA Boot Camp: Appreciating the Nuances of the Approval Process for Controlled Substances1 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
- EventsACI’s 21st Annual Rx 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
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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
- EventsASPL Roundtable: The Impact of Roe v. Wade's Reversal on Pharmacies and PharmacistsSeptember 9, 20222 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
- EventsAmerican Conference Institute: Compliance Think Tank — Building an Effective Controlled Substances Compliance ProgramJuly 11, 20222 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
