Overview
For life sciences companies developing new technologies and treatments that improve lives, success hinges on far more than following the letter of the law. At Epstein Becker Green, we translate legal advice into practical action. Our team of lawyers and non-lawyer consultants and advisors offers real-world experience from careers in all corners of the life sciences industry.
We understand the unique legal, regulatory, compliance, operations, and technology challenges facing life sciences companies. Because of the diversity and breadth of experience of our Life Sciences team, we successfully meet the needs of our life sciences clients, from early pre-clinical research to commercialization and product launch through commercial operations, providing support for compliance with legal requirements over the entire product lifecycle. Our clients include pharmaceutical, biotechnology, medical device, and other life science industry companies.
Use Our Integrated Approach to Your Advantage
Life science companies require practical and comprehensive support as they discover, develop, and commercialize novel medical technologies to meet the needs of patients. Our attorneys partner with our affiliate, EBG Advisors, giving clients unrivaled access to non-lawyer consultants and advisors. Working as an extension of our firm, a diverse team of former physicians, health plan medical directors, reimbursement specialists, quality and regulatory experts, and government agency officials leverage their insight to tackle challenging regulatory hurdles.
Research and Development Solutions with Lasting Results
Tomorrow’s medical breakthroughs are founded on today’s innovative research. Clients turn to us for advice on the best way to secure investments for new research and to structure collaborative research and development transactions. We also negotiate collaboration terms, clinical site contracts, and services agreements with contract research organizations and other research services vendors.
Sophisticated Counsel for Corporate Transactions
Life sciences clients looking to grow or sell their companies count on us to help them evaluate targets for mergers, acquisitions, joint ventures, and sales, as well as to successfully structure and close their deals. We also represent private equity funds and other investors in financing transactions with life sciences companies. Because we have in-depth knowledge of the life sciences industry, and the laws and regulations that apply to it, we can easily spot and resolve potential problems that can arise during these transactions.
Corporate Compliance and Training Programs That Support Growth
In the fast-paced life science landscape, compliance programs are never static and may cover multiple jurisdictions spanning various supply chains and numerous third parties. While no two compliance programs are alike, risk management drives a company’s ability to anticipate enforcement agency priorities. We help clients define and assess their risks and develop compliance infrastructure and training programs that support their business goals.
Litigation and Dispute Resolution Services to Protect Your Interests
The complexity of the highly regulated life sciences industry has increasingly led to litigation among life sciences companies and their competitors, collaborators, consumers, and others, as well as by federal and state law enforcement agencies and qui tam relators. Our litigation attorneys, including some with high-level governmental prosecutorial backgrounds, are experienced in guiding life sciences clients through investigations, enforcement actions, and lawsuits. We represent and defend our clients in federal and state trial and appellate courts and before administrative and private tribunals in civil and criminal cases.
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Focus Areas
Services
- Academic and Clinical Research
- Artificial Intelligence
- Corporate Compliance Program Development, Implementation, and Effectiveness
- Digital Health
- Drug and Medical Device Coding, Coverage, and Payment
- Drug and Medical Device Distribution
- Drug Pricing Policy & Reporting
- FDA Inspections and Enforcement
- Federal and State False Claims Act (Including Qui Tam)
- Federal Research Grants: Compliance, Investigations & Enforcement
- General Counsel Services
- Health Care and Life Sciences Investigations and Enforcement
- Health Care and Life Sciences Investor Services
- Health Care Mergers and Acquisitions
- Health Policy and Legislation
- Industry Research and Clinical Trials
- Life Sciences Due Diligence
- Mergers, Acquisitions & Divestitures
- Product Marketing and Compliance
- Regulatory Strategy, Product Development, and Product Approvals
Industries
Experience
Our Team
Media
Events
Upcoming Events
- December 10-11, 2024
Past Events
Insights
Insights
- Media CoverageRichard Hughes Quoted in “Scientists and RFK Jr. Want Vaccine Data—for Very Different Reasons”3 minute read
- BlogsUnpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software6 minute read
- BlogsExemptions from the Drug Supply Chain Security Act Enhanced Drug Distribution Security Requirements7 minute read
- PublicationsAre We Ready for a Bird Flu Vaccination Campaign?2 minute read
- BlogsUnpacking Averages: Assessing FDA’s Postmarket Surveillance Under Section 52211 minute read
- Firm Announcements
Four Epstein Becker Green Attorneys Named to the 2024 Massachusetts Super Lawyers and Rising Stars Lists
8 minute read - BlogsVideo: New State Legislation Increases Oversight of Health Care Transactions – Thought Leaders in Health Law2 minute read
- BlogsUnited States’ Complaint-in-Intervention Highlights Continuing Effort to Use the False Claims Act to Pursue Alleged ...5 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
- 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
- Media Coverage
Richard 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
- BlogsCMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin ...13 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
- 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
- BlogsFDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners13 minute read
- Blogs
How Does the End of Chevron Deference Change the Relationship Between the Health Care Industry, Federal Regulators, and ...
12 minute read - BlogsPodcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care2 minute read
- BlogsPodcast: Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court – Diagnosing Health Care2 minute read
- PublicationsFDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans16 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
- 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 “‘A Mixed Bag’: Fifth Circuit Rules on ACA Preventive Services Legal Case”3 minute read
- Media CoverageRichard Hughes Quoted in “Fifth Circuit Maintains ACA Preventive Mandate; but Remands Vaccine, Birth Control” ...1 minute read
- Media CoverageRichard Hughes Quoted in “Appeals Court Finds 'Obamacare' Pillar Unconstitutional in Suit Over HIV-Prevention Drug” ...3 minute read
- BlogsPodcast: If Cannabis Is Reclassified, What Will Happen to the Marketplace? – Diagnosing Health Care2 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, Misleading ...5 minute read
- Blogs
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
41 minute read - 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 ...16 minute read
- BlogsIt’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices ...8 minute read
- PublicationsFive Commissioners and a Vote on Noncompetes to Come2 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
- PublicationsFTC Continues Investigation into PBM Practices2 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 ...9 minute read
- BlogsFifth Circuit Poised to Uphold Ruling Striking Down Preventive Coverage Requirement4 minute read