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Linda Pissott Reig, shareholder, and Phillip V. DeFedele, associate, in our life sciences and pharmaceutical section authored several chapters in a newly released book from Practising Law Institute (PLI) titled, “Pharmaceutical Compliance and Enforcement Answer Book.”

In 2016 and 2017, Linda authored Chapters 9 and 10,  titled “Risk Evaluation and Mitigation Strategies (REMS) and Related Post-Market Safety Oversight” and “Impact of FDA Regulatory and Compliance Oversight on Product Liability Exposure of Pharmaceutical Manufacturers.”  Phillip authored Chapter 7, titled “Current Status of the Impact of the First Amendment on Off-Label Promotion.

In 2015, Linda authored Chapter 9, titled, "Risk Evaluation and Mitigation Strategies (REMS) and Related Post-Market Safety Oversight."