Regulatory Strategy, Product Development, and Product Approvals

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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Experience

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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.