Developing an FDA regulated product, obtaining the necessary approval or clearance, managing your supply chain, preparing for inspections and audits, marketing the product and responding to enforcement actions - can all present a daunting array of challenges and opportunities for your company.

Our team at Reed Smith focuses on the FDA regulations of numerous products, including drugs, medical devices, biologics, dietary supplements and biotechnology products; through the entire product life cycle from conducting clinical trials through post-market activities. We can advise you on viable pathways to expedite development and review of new prescription (Rx) and over-the-counter (OTC) products and to obtain any approvals or clearances with market protections wherever available and possible.