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Food, Drug & Device/FDA

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Alston & Bird’s FDA attorneys represent and counsel clients on a wide range of FDA regulatory compliance matters affecting prescription and OTC drugs, biologics, medical devices, food, cosmetics and tobacco. We assist senior management teams with crisis management and work with clients to identify and analyze potential legal risks associated with their products. Our experience includes highly visible litigation, as well as discreet resolution of potentially serious charges. We have extensive experience with issues occurring throughout the product life cycle, including those related to clinical trials, market entry, current good manufacturing practices (CGMPs), quality system regulations (QSRs) and product promotion. We also provide regulatory advice and FDA due diligence support for corporate financing, as well as mergers and acquisitions. On legislative matters, we assist in the development of strategies, help with testimony, prepare clients for interviews with congressional committee staff and provide advice on pending legislation.