Shelby Riney, counsel in the firm's Commercial Litigation Department, authored Chapter 6: Post Approval Commitments in "FDA Basics for the Drug and Medical Device Lawyer." The book is designed to be a go-to reference guide for drug and device litigators, with straightforward explanations of the FDA’s regulation of the drug and medical device industry, including approval applications and processes, labeling, advertising and promotion, manufacturing, and post-approval commitments.
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