Jennifer Mallory, Partner, Nelson Mullins Riley & Scarborough LLP to Speak at The Knowledge Group’s Webcast

Top Quote The Knowledge Group has announced today that Jennifer Mallory, Partner, Nelson Mullins Riley & Scarborough LLP will speak at its webcast entitled: “Food and Drug Regulatory Trends and Developments: Navigating Implications for the Year Ahead”. This event is scheduled on August 5, 2020 from 3:00 pm to 4:00 pm (ET). End Quote
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    About Jennifer Mallory
    Jennifer Mallory is a partner at Nelson Mullins Riley & Scarborough’s flagship office in Columbia, South Carolina where she focuses her practice in the areas of food, drug, and device law as well as clinical research, bioethics, and business and intellectual property litigation. She has served as a member of several boards including the Medical University of South Carolina Institutional Review Board, S.C. Bar Board of Governors, and the Rutland Ethics Alliance. Mallory holds graduate certificates in Clinical Research and the Law and in FDA Regulation and Liability—both from Seton Hall University School of Law. She earned her JD from Washington and Lee University School of Law and her BA from the University of South Carolina, cum laude.

    About Nelson Mullins Riley & Scarborough LLP
    Nelson Mullins is an AmLaw 100 firm serving clients in more than 100 diversified practice areas. From a firm of one attorney in 1897 to 800+ attorneys, policy advisors, and professionals in 11 states and the District of Columbia today, we represent corporate and individual clients in a wide variety of areas, including: food/drug/device law, regulatory, healthcare, litigation, intellectual property, real estate capital markets, corporate, technology, banking, e-discovery, economic development, securities, finance, tax, estate planning, governmental relations, environmental, real estate, labor and employment, privacy and security, and white collar crime. Nelson Mullins’ clients range from Fortune 500 companies to private equity and venture funds and portfolio companies to emerging growth companies and start-ups.

    Event Synopsis:
    The COVID-19 pandemic has resulted in a major shift in FDA regulatory and enforcement priorities and has had a drastic impact on the broader regulatory landscape. At the end of 2019, the agency was focused, among other issues, on opioids, youth vaping, food safety, compounding and overhauling the regulatory framework for dietary supplements. Today, FDA is focused on helping industry bring to market drugs, devices and vaccines critical to fighting the pandemic. Its enforcement efforts are focused on those who peddle false cures or distribute counterfeit or otherwise poor quality products. The world has changed, and with it the regulatory environment.

    FDA has issued guidances and templates to help industry develop substantive emergency use authorization requests with sufficient information to enable effective and streamlined review, exercised enforcement discretion where it deemed the benefits outweighed the risks, and waived regulatory requirements to help get products to market quickly. And FDA has indicated its willingness to “course correct” when evidence has demonstrated that the agency’s flexibility resulted in more harm than good. FDA is also providing significant trial design assistance and wading into thorny ethical issues in connection with the race to develop a vaccine.

    There may be long-lasting effects from the pandemic even after the immediate threat abates. Going forward, companies may opt to reevaluate their supply chains, taking into consideration the shortages seen during the pandemic attributable in part to the country’s reliance on foreign sources of API, finished drugs, and devices like N95 masks. FDA has also shown willingness to use real world evidence as it evaluates COVID-19 therapeutics and has welcomed digital health applications that enable remote monitoring of clinical trial subjects and remote evaluation and treatment of sick patients. Certain changes may remain after the pandemic subsides and the current public health emergency declaration is lifted.

    In this webcast, Beth P. Weinman (Ropes & Gray LLP) and Jennifer Mallory (Nelson Mullins Riley & Scarborough LLP) will address the above topics as they provide an overview of the impact of COVID-19 on the FDA regulatory environment.

    About The Knowledge Group
    The Knowledge Group is a leading provider of Continuing Legal Education, CLE, for lawyers, Continuing Professional Education, CPE, for accountants and a variety of other types of continuing education for other professions. Our mission is to deliver quality continuing education programs utilizing industry trends and the latest technology to communicate regulatory shifts and contributions made to different fields. Our insightful and engaging webcasts are brought to you by leading influencers to offer a multitude of perspectives and outlooks.

    In bringing together thought leaders, regulators, and subject matter experts from around the world, The Knowledge Group strives to be the best-in-class provider of continuing education. The experts we engage with analyze the latest trends, insights, and developments in their industries to bring forth content you can’t get anywhere else.

    We can be reached via our website, over the phone at (646) 844-0200 or email us at info ( @ ) theknowledgegroup dot org. We look forward to having you learn with The Knowledge Group.

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