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.
- Supported clients’ regulatory strategy and submissions to FDA and other regulatory authorities, including premarket notifications (510(k)s), premarket approvals, NDAs, and abbreviated NDAs.
- 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.