October 31, 2020

Volume X, Number 305

Linda D. Bentley

Linda relies on her extensive knowledge of the FDA and other agencies that regulate pharmaceutical, biotechnology, and medical device companies and products to advise clients on regulatory and related business issues. She is well-versed in the intersection of technology, regulatory requirements, clinical trials and health care, and counsels clients developing and investing in innovative and cutting-edge products.

Linda has extensive experience representing pharmaceutical, biotechnology, and medical device companies and investors on compliance with the Federal Food, Drug, and Cosmetic Act, including the regulation of products targeting cell, tissue and gene therapies, companion diagnostics, and combination products. She also provides advice on arrangements for outsourced services and advertising and other promotional issues. Because of her extensive knowledge of the requirements that apply to most types of FDA-regulated businesses, she is able to efficiently perform regulatory and clinical due diligence for financings and other corporate transactions and counsels clients on disclosure of clinical, regulatory and other product-related developments. In addition, she has worked with companies to obtain reimbursement from insurance companies, managed care organizations and Medicare.

Before attending law school, Linda was Director of Regulatory Affairs for New England Nuclear/DuPont Medical Products, where she established and implemented the company’s FDA policies and was responsible for administering clinical trials and instrumental in obtaining marketing approval for several new products in the United States, Canada, and other countries. She continued to provide FDA consulting services to pharmaceutical and medical device companies while she was in law school.

Articles in the National Law Review database by Linda D. Bentley

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