Medical device, drug, and biologics companies that comply with the FDA requirements of their product class, encounter new and unfamiliar compliance requirements when they decide to develop and market combination products. In addition to drug, biologics, or device requirements that are alien to their compliance cultures, they also encounter unprecedented new requirements and compliance issues that are peculiar to the combination product classification itself.
FDA policy and procedures for regulating combination products are emerging slowly and are largely in the draft stage. In the interim, the agency has defaulted to a case-by-case approach to defining requirements for a particular combination product. As a result, manufacturers find themselves facing a new, complex and often ill-defined regulatory framework that creates challenges throughout the life cycle of Combination Products
Manufacturers of Combination Products are subject to the approval and compliance requirements of multiple FDA centers with different, and sometimes conflicting, regulatory perspectives, processes and procedures. This reality creates decision-making and compliance issues for manufacturers at every phase of the product life cycle. Anson Group consultants are familiar with these potential issues, and are experienced in assisting manufacturers to navigate through them.
Broad Expertise: Anson has helped clients of all sizes and product classifications to meet the evolving challenges of combination product regulation. We work with drug, device, and biologics Clients, ranging from development stage companies to major corporations, to provide them with a continuum of FDA compliance services spanning the product life cycle.
Relevant Experience: Anson has served as expert intermediaries with FDA for Clients from the early beginnings of combination product regulation, through the formation of the Office of Combination Products, to the present. Through our relationship with the Agency, we have also contributed to progress in developing regulatory policies and proposals to ease burdens on industry. In addition, Anson provides assistance to the Combination Products Coalition (CPC, www.combinationproducts.com), a group of leading companies in the drug, device, and biologics industries that is working to improve the regulatory environment for combination products through development and advocacy of policy positions on regulatory issues affecting combination products.
The Knowledge to Respond: Anson has a history of providing Clients with Corporate Compliance Assessment services, using tools which we helped develop and are now applying to help them adapt to the complexities and risks of combination product compliance.
