53 matches.
- PublicationsSolving the EDDO Guidance Puzzle1 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
- Firm AnnouncementsEpstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 202514 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
- Firm AnnouncementsEpstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession12 minute read
- Media CoverageBonnie Odom Quoted in “Health Care’s AI Embrace Boosts Workforce Despite Privacy Risks”2 minute read
- PublicationsCongress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs14 minute read
- PublicationsIn Vitro Diagnostic (IVD) Devices2 minute read
- Media CoverageLaw360 Names the 10 Epstein Becker Green Attorneys Who Moved Up the Ranks in 20222 minute read
DOJ Goes After Civil Cyber-Fraud
Firm AnnouncementsEpstein Becker Green Announces 2022 Promotions6 minute read-
Is the Dietary Supplement Regulatory Framework Working?
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President Biden’s Use of the Defense Production Act
- BlogsBuilding Compliance Programs for AI Tools3 minute read
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Forecast for Telehealth Fraud and Abuse Risk in 2021
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Key Considerations for Reshoring U.S. Drug Manufacturing
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Fraud and Abuse Enforcement Priorities in the Wake of COVID-19
- BlogsFDA Eases Device Modification Rules to Expand Availability of Ventilators During COVID-19 Pandemic6 minute read
- PublicationsOIG Permits Manufacturer of Personalized Medicine Drug to Cover Patients' Travel, Lodging, and Other Expenses9 minute read
- BlogsWhat’s New in E-Cigarette Regulation?5 minute read
- BlogsThe Role of Patient Preference in Medical Device Evaluation4 minute read
- BlogsObscure FDA Device Reporting Exemptions Draw Patient and Provider Concern4 minute read
- BlogsFDA Loosens the Reins on Informed Consent Requirements for Certain Clinical Studies5 minute read
- PublicationsResponse to RFIs: EBG Submits Comments to CMS on Stark Law Reforms and Is Preparing Comments to OIG on Anti-Kickback Statute and Beneficiary Inducement CMP Modifications8 minute read
- BlogsFDA Makes Moves to Advance Digital Health6 minute read
- BlogsNew Federal and State Initiatives Seek to Combat Antimicrobial Resistance6 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
- BlogsWearables in the Workplace: Promise and Pitfalls6 minute read
- PublicationsFive Trending Challenges Facing Employers in the Technology, Media, and Telecommunications Industry28 minute read
- BlogsFCA Penalty Spike Confirmed by DOJ2 minute read
- EventsFDA Regulatory Environment for Wearables, Implantables, and Other Digital Health Devices - Wearables Crash Course Webinar Series2 minute read
- BlogsHealth Care Providers May Soon See a Twofold Increase in False Claims Act Penalties5 minute read
- Firm AnnouncementsEpstein Becker Green Releases Comprehensive 50-State Survey on Telemental Health Laws in the United States6 minute read
- PublicationsUsing Social Media to Monitor Postmarket Drug Safety2 minute read
- Media CoverageBonnie Scott Featured in Q&A "Why 3D Printing Has 'Tremendous Potential' for Big Pharma"2 minute read
- BlogsFDA Leverages Patient-Reported Information to Monitor Drug Safety4 minute read
- Blogs3-D Printing Guidance Only a B-List Priority for FDA3 minute read
- PublicationsLegal Health: What's New in 3-D Printing?2 minute read
- BlogsWhat's the Latest in 3-D Printing?7 minute read
- PublicationsNIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations42 minute read
- Blogs3-D Printed Devices Pose Layers of Regulatory Questions5 minute read
- PublicationsFDA Releases Draft Guidance Updating Agency Policies on the Informed Consent Process for Clinical Trials13 minute read
- PublicationsRecent District Court Case Highlights State Variation in Applying Corporate Practice of Medicine and Global Billing Restrictions to MRI Providers9 minute read
- PublicationsDraft Framework for Interstate Medical Licensure Compact Released7 minute read
- PublicationsThe EYES Have it: Harnessing the Power of Eye Contact in the Workplace, on the Executive Women's Networking Blog1 minute read
- PublicationsProactively Approaching Telehealth Informed Consent, on the TechHealth Perspectives Blog1 minute read
- BlogsProactively Approaching Telehealth Informed Consent5 minute read
- PublicationsHow to Physically Secure Electronic PHI1 minute read
- BlogsPhysically Securing Electronic PHI in a Telehealth Environment6 minute read
- PublicationsThe Forecast for RAC Extrapolation: Mostly Cloudy, in Healthcare Financial Management1 minute read
- PublicationsOversight Overhaul: Eliminating the Premarket Review of Medical Devices and Implementing a Provider-Centered Postmarket Surveillance Strategy, in Food & Drug Law Journal1 minute read
- PublicationsProvider Experiences with RAC Appeals Point to Opportunities for Program Improvement, in Healthcare Financial Management1 minute read