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
Trending Issues
Experience
Our Team
Media
Events
Upcoming Events
- June 17 and 21, 2024
Past Events
Insights
Insights
- 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
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- 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
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- Publications
Will Religious Freedom Claims Trump Public Health? Braidwood and HIV Prevention
2 minute read - Media CoverageRichard Hughes Quoted in “ObamaCare Faces Key Hearing After Texas Ruling”2 minute read
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- 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
- BlogsIn Alabama, Pre-Embryos are “Extrauterine Children” Under the State’s Wrongful Death Statute11 minute read
- Media CoverageRichard Hughes Quoted in “Doc Pay Patch Could Emerge in Scaled-Back Health Package; Budget Talks Continue”2 minute read
- BlogsFDA Releases Updated Directory on Select Dietary Supplement Ingredients5 minute read
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- BlogsUnpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are ...10 minute read
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- 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 ...10 minute read
- BlogsUnpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic10 minute read
- BlogsSharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft ...14 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 Industries ...6 minute read
- PublicationsCMS Seeks Stakeholder Feedback About Medicare Transaction Facilitator Services for the Medicare Drug Price Negotiation ...4 minute read
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- PublicationsORI Releases Notice of Proposed Rulemaking to Update 2005 Public Health Service Policies on Research Misconduct ...7 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- PublicationsA Topic-Based Analysis of FDA Responses to FOIA Requests1 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 ...25 minute read
- Firm Announcements
Epstein Becker Green Receives New York Law Journal’s 2023 Innovation Award
4 minute read - PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New ...26 minute read
- PublicationsCMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates7 minute read
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- Firm Announcements
Jessika Tuazon Named to the 2023 Southern California Rising Stars List
6 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 Updates ...2 minute read