Overview
Medical device, pharmaceutical, and biotechnology companies face many complex challenges as they develop innovations for the market. But with experienced legal counsel, those challenges can be navigated successfully.
At Epstein Becker Green, we use our in-depth industry insight to help clients transform their nascent product development objectives into actionable development strategies and achieve U.S. Food and Drug Administration (FDA) approval. Post-approval, clients value our counsel to maintain FDA-compliant manufacturing practices, promotional strategies, post-marketing surveillance, and distribution controls.
We Understand the FDA
We act as our clients’ window into the FDA. Working with EBG Advisors, Inc., our affiliated national strategy and management consultancy based in Washington, DC, we harness our collective knowledge of the intricacies of FDA regulation to position our clients favorably in their interactions with the agency. Consultants on our team previously held roles in the FDA, giving us insight into how the agency works and informing strategies for better outcomes. We advocate for our clients by drawing on our proven tactics and thinking outside the box, when necessary, to pursue the most efficient path to approval.
Navigating Requirements for Emerging Products
By partnering early in the development process, we help to guide our clients’ marketing plans with an eye toward health plan coverage and reimbursement, as well as future promotional claims and marketing strategies. With that perspective, we advise clients on the best pathways to achieve their reimbursement and commercial objectives. When seeking FDA approval, clients rely on our knowledge of best practices to navigate every step of the submission process. For products that may be considered exempt from FDA clearance or approval, such as Class 1 FDA-exempt devices, OTC monograph drugs, and certain human cell or tissue-based products (HCT/Ps), we help clients develop appropriate marketing strategies and ensure they maintain promotional practices to avoid triggering additional regulatory obligations.
Maintaining Compliance with Good Manufacturing Practices
At Epstein Becker Green, we don't just help clients achieve FDA compliance, we help them maintain it. Clients with developed products regularly seek our advice to understand and adhere to their obligations for FDA-compliant manufacturing and distribution practices. We assist with GMP/Quality System development, FDA inspection readiness, remediation of inspection findings, and responses to Warning and Untitled Letters. Clients also rely on our guidance when determining the need for, and interfacing with FDA about, recalls.
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Focus Areas
Experience
- Advised a tissue product manufacturer regarding the FDA regulatory status and marketing pathway for various cellular and tissue products.
- Supported a medical device manufacturer’s development and implementation of a marketing strategy and a claims library for medical devices used in the preparation of regenerative therapy treatments.
- Supported a client’s regulatory strategy and submissions to the FDA and other regulatory authorities, including premarket notifications (510(k)s), premarket approvals, new drug applications (NDAs), abbreviated NDAs, and biologics license applications.
- Advised a development-stage pharmaceutical manufacturer launching its first offering in coordination with its global pharmaceutical manufacturer commercialization partner. Epstein Becker Green provided health regulatory counsel for negotiations with U.S. and global research providers and guided the expansion of the company’s corporate compliance, medical affairs, commercial operations, and scientific and commercial communications programs.
- Drafted and submitted a citizen petition to the FDA on behalf of a client, raising safety concerns about a first-in-class drug and asking the FDA to take a closer look at those issues before approval. The FDA referred the application to an advisory committee (ADCOM) for review, while Epstein Becker Green submitted comments for the ADCOM’s consideration. Consistent with the ADCOM’s recommendation, the FDA requested that the applicant conduct an additional clinical trial before it again considers approval of the drug.
- Advised a multibillion-dollar global pharmaceutical company on regulatory strategy for its first digital health solution and provided advice on marketing claims and a commercialization plan.
- Developed regulatory strategies for medication adherence mobile technologies connected to drug delivery systems for a global medical device and diagnostic company.
- Provided FDA compliance guidance for a European mobile-based health tracking application that uses an algorithm-based system to track and analyze health data and predict outcomes for personal health decision-making.
- Provided regulatory guidance to a health and wellness startup seeking FDA approval to use AI and machine learning to help patients live independently and manage their various health conditions.
Contacts
- Member of the Firm
- Member of the Firm
Media
Events
Upcoming Events
- December 10-11, 2024
Past Events
Insights
Insights
- Media CoverageLisa Pierce Reisz Quoted in “New Health Apps May Pose Challenges to Patient Privacy”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Convergence: Experts Offer Advice on Leveraging AI in Regulatory”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 CoverageChristopher Smith Quoted in “HDA 2024 Traceability Seminar: A Legal Perspective Regarding DSCSA”5 minute read
- Media CoverageDavid Shillcutt Quoted in “Proposed Digital Therapy Codes Good Idea with Barriers: Experts”2 minute read
- Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- BlogsPodcast: The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care2 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
- BlogsPodcast: If Cannabis Is Reclassified, What Will Happen to the Marketplace? – Diagnosing Health Care2 minute read
- BlogsFDA Wins Mifepristone Case, NLRB Denied Lower Injunctive Relief Standards, and “Trump Too Small” Denied Trademark ...7 minute read
- Media CoverageBradley Merrill Thompson Cited in “AI Regulation: Global Picture Balances Innovation and Insight”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Experts Advise Against Prescriptive FDA Policies for Regulating AI”3 minute read
- Media CoverageRachel Snyder Good Quoted in “A First in State AI Law”2 minute read
- Blogs
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
41 minute read - Media CoverageJames Boiani Quoted in “Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval”5 minute read
- PublicationsThe Legal and Reputational Risks Associated with Greenwashing3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Warned of Removing Guidance Comment Period in Proposed Plan”2 minute read
- PublicationsHealth Care M&A Insights: Q4 2023 & Outlook for 2024 Deal Activity4 minute read
- Media CoverageBradley Merrill Thompson Discusses “Problematic Guidance Patterns Remain at FDA”2 minute read
- PublicationsEnsure Equity and Feasibility in Updating Meningococcal Vaccine Recommendations2 minute read
- Media CoverageBradley Merrill Thompson Discusses Clinical Decision Support, Medical Devices, and AI in Yale Video1 minute read
- Media CoverageJames Boiani Quoted in “Clinical Lab Consolidation Continues in 2023 While Key Policy Questions Go Unresolved” ...2 minute read
- Media CoverageJames Boiani Quoted in “FDA Braces for High Court, Final Rule Moves in Election Year”3 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2024 Promotions6 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
- Media CoverageJames Boiani Quoted in “FDA Moving Quickly on LDT Rulemaking as 2024 Elections, 2027 User Fee Renewal Loom” ...2 minute read
- Media CoverageRachel Snyder Good Quoted in “'Devil's in the Details' of Biden's AI Health Plans, Experts Say”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI vs. the Health Bureaucracy”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The Problem with FDA's Warning to Abiomed”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI Has Arrived in Your Doctor’s Office. Washington Doesn’t Know What to Do About ...4 minute read
- PublicationsNavigating the Medtech GenAI Journey: A Policy Primer2 minute read
- Media CoverageJames Boiani Quoted in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation”5 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- Media CoverageJames Boiani Quoted in “FDA Wants Oversight of Lab-Developed Tests”2 minute read
- BlogsFDA Oversight of AI Software Developed by Health Care Providers23 minute read
- PublicationsDietary Supplement Makers Face "Misbranding" Minefield, Need FDA Guidance7 minute read
- BlogsFDA’s LDT Proposed Rule Heads to the White House2 minute read
- BlogsTAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year26 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA, Industry Coalition Still at Odds Over September 2022 CDS Final Guidance” ...2 minute read
- Firm Announcements
Jessika Tuazon Named to the 2023 Southern California Rising Stars List
6 minute read - PublicationsBy Leaving "Therapeutic Alternatives" Undefined, CMS Tilts the Playing Field of Drug Price Negotiations3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Ready or Not, AI Chatbots Are Coming to Hospitals”3 minute read
- PublicationsWhy a Data Scientist Needs a Lawyer to Correct Algorithmic Discrimination4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance Allows AI/ML Devices to Evolve Without Requiring New ...5 minute read
- PublicationsBradley Merrill Thompson Quoted in “FDA’s Human Factors Draft Draws Fire for Introduction of ‘Critical Task’ ...2 minute read
- PublicationsReminder of March 31 “Right to Try” Reporting Deadline8 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Outlines Plan for Digital Health Technologies for Clinical Trials”4 minute read