Overview
Medical device, pharmaceutical, and biotechnology companies face many complex challenges as they develop new innovations for 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
Clients with developed products regularly seek our advice to understand and adhere to their obligations for FDA-compliant manufacturing and distribution practices. We help clients with GMP/Quality System development, FDA inspection readiness, remediation of inspection findings, and responses to Warning and Untitled Letters. Clients also seek our guidance on 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
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Media
Events
Upcoming Events
Past Events
- March 22, 2023
- March 13, 2023
Insights
Insights
- 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
- 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
- Firm Announcements
Epstein Becker Green Recognized Among Top 10 Largest Health Care Law Firms by Modern Healthcare
2 minute read - PublicationsIs Federal Trade Commission at War with the Dietary Supplement Industry?2 minute read
- Media CoverageJames Boiani Quoted in “FDA Resumes Move to Regulate LDTs, Likely Setting Up Legal Battle with Lab Industry” ...3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Growth of AI in Mental Health Raises Fears of Its Ability to Run Wild”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The FDA Plans to Regulate Far More AI Tools as Devices. The Industry Won’t Go Down ...2 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Regulatory Hurdles for Breakthrough Devices2 minute read
- Media CoverageBradley Merrill Thompson and the CDS Coalition Request FDA Rescind Final Decision Support Guidance2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Why Congress Quietly Just Gave the FDA More Power”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Industry Group Petitions FDA to Withdraw CDS Guidance”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Trade Group Pushes Back on FDA’s Clinical Decision Support Guidance”3 minute read
- PublicationsFDA Significantly Reforms Cosmetics Regulations for First Time in Over 80 Years11 minute read
- PublicationsCongress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs ...14 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in “And Over at FDA …”2 minute read
- PublicationsFTC’s Revisions to Dietary Supplement Advertising Guidelines: More of the Same2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Outlook 2023: The Regulatory Path Ahead”2 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- Media CoverageDelia Deschaine Quoted in “Abortion Pill Opponents Seize New Chance to Target FDA Approval”3 minute read
- Media CoverageBradley Merrill Thompson Discusses “The Impact of Clinical Decision Support Software on the Healthcare Industry” ...2 minute read
- Media CoverageOffice Snapshot: Epstein Becker Green's New Nashville Outpost3 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2023 PromotionsOctober 28, 20225 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software to Predict Risk of Sepsis, Stroke Should Be Regulated as a Medical Device ...4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Tweak of Mobile Medical Apps Guidance Introduces Transparency ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Acknowledges Shortcomings of Pre-Cert Pilot in Report”6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Lays Out CDS Stance”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Legal Expert: FDA’s CDS Software Guidance Is a ‘Disaster’ for Industry” ...3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Finalizes Guidance on How Clinical Decision Support Software Is Regulated” ...2 minute read