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Linda D. Bentley

Member

[email protected]

+1.617.348.1784

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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.

Education

  • Boston College (JD)
  • Simmons College (BS)

Recognition & Awards

  • Martindale-Hubbell AV Preeminent
  • Massachusetts Super Lawyers: FDA (multiple years)

Involvement

  • Food and Drug Law Institute (FDLI): Medical Devices Committee
  • Former Director, Massachusetts Medical Device Industries Council (MassMEDIC) (2000 - 2006)
  • Member, MassMEDIC FDA Working Group
  • Former Director, MedTech IGNITE, a MassMEDIC program for medical device entrepreneur (2006 - 2015)
  • Advisory Board, Bloomberg BNA’s Pharmaceutical Law & Industry Report
  • Advisory Board, Bloomberg BNA’s Medical Devices Law & Industry Report
  • Invited Member, NEWISE (New England Women in Science Executives Club)
  • Board of Overseers, Boston Ballet
  • Member, American Health Lawyers Association
  • Member, Massachusetts Bar Association
  • Member, Boston Bar Association

Languages

- French

- German

- Hebrew

Recent Insights

News & Press

Viewpoints

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation.
The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company with offices in France and New Jersey, regarding the company’s conduct as a sponsor of several clinical trials is noteworthy.
After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress on July 31, 2014 that it intends to issue a draft guidance document entitled, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and an accompanying draft guidance document entitled, “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).”
In what has been an active couple of months of released guidance documents, the FDA issued another draft guidance on June 20, 2014 entitled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.”

News & Press

This article, authored by Member Linda Bentley, discusses the U.S. Food and Drug Administration’s (FDA) historic step approving the first drug in the United States that contains a purified drug substance derived from marijuana.
Member Linda Bentley was quoted in this article discussing the Food and Drug Administration’s (FDA) proposed new and more flexible approach to clear certain medical devices.
Mintz represents NuCana, which completed its approximately $114 million initial public offering. The United Kingdom-based clinical-stage company focuses on improving treatment outcomes for patients with cancer.
Mintz represented G1 Therapeutics, Inc. in its initial public offering of 7,781,564 shares of common stock. G1 Therapeutics is a clinical-stage biopharmaceutical company.
Mintz Member Linda Bentley was quoted in a Bloomberg BNA Life Sciences Law & Industry Report article on the life sciences industry’s uncertainty regarding the Trump administration’s enforcement of the Foreign Corrupt Practices Act (FCPA).
Mintz Member Linda Bentley is quoted in a Bloomberg BNA Health Care Daily Report article highlighting thoughts from two drug industry trade organizations regarding how the FDA “re-evaluate how it regulates off-label communication between drugmakers and health-care professionals.”
Linda Bentley, a Mintz Member, is quoted in a BNA’s Pharmaceutical Law & Industry Report article covering the FDA’s issued draft guidance intended to clarify the role of data integrity in current good manufacturing practice for drugs.  
The Medical Devices Law & Industry Report is an in-depth, interdisciplinary news coverage of all major developments in the rapidly changing medical devices industry. The report quotes Linda Bentley, a Member in the Mintz Boston office.   
This BNA’s Pharmaceutical Law & Industry Report article focuses on the major points of discussion for drug and biotech companies in 2016, including reauthorization of drug user fee programs, drug pricing, and matters pertaining to biosimilars. Mintz Member Linda Bentley is quoted in the piece.

Events

Speaker
Speaker
Mar
16
2017