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Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice. We are thinking of all of you in these difficult times, and hope all of you and your loved ones are safe.

In This Issue

Industry Insights

It Is Not All About the Coronavirus Part 2: The CARES Act Brings Reforms to the Medical Device Industry
By: Alan G. Minsk and Genevieve M. Razick

President Donald Trump signed the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) into law on March 27, 2020, to help mitigate the economic effects of the Coronavirus Disease 2019 (COVID-19) pandemic. In addition to providing substantial resources to combat the sharp economic decline due to the COVID-19 pandemic, the CARES Act also includes a number of provisions to further healthcare preparedness and response, including provisions aimed at the medical device industry. More >

To read Part 1 of this series, “It Is Not All About the Coronavirus: The CARES Act Brings Long-Awaited Over-the-Counter (OTC) Monograph Reform,” please click here

Q&A: The CARES ACT and OTC Drug Reform in 2020
By: Carolina M. Wirth and Genevieve M. Razick

In March 2020, the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) ushered in a wave of reforms to modernize the regulation of over-the-counter (OTC) drugs in the United States. A summary of some of the key provisions can be found in our bulletin entitled, “It Is Not All About the Coronavirus: The CARES Act Brings Long-Awaited Over-the-Counter (OTC) Monograph Reform.” Since we published that summary, we have received many questions concerning the upcoming changes to the OTC Drug Review process. We prepared the list below of some commonly asked questions and answers. More >

With One Warning Letter, FDA Demonstrates Many of the Ways It Can Establish the Intended Use of a Product Labeled as a Dietary Supplement
By: Robert Durkin

On March 31, 2020, the Food and Drug Administration issued a Warning Letter to a dietary supplement firm for making claims about its products that establish the products are unapproved new drugs, in violation of Federal Food, Drug, and Cosmetic Act (FD&C Act), because they are intended to cure, mitigate, treat, or prevent disease. In the Warning Letter, FDA outlined numerous claims that it observed on the company’s websites, Amazon storefront, and social media accounts for the products, which served as evidence of the products’ intended uses. More >

HHS Issues New Guidance on PREP Act Immunity When Prescribing, Administering, or Dispensing Drugs and Devices for COVID-19
By: Rebekah N. Plowman and Charmaine A. Mech

On April 14, 2020, the Department of Health and Human Services (HHS) issued an Advisory Opinion, which provided additional clarification on immunity provided under the Public Readiness and Emergency Preparedness Act (PREP Act) Declaration related to Coronavirus Disease 2019 (COVID-19). This article provides an overview of the PREP Act immunity for health professionals and provider entities prescribing, administering, or dispensing drugs, biologics, vaccines, or devices to treat, diagnose, cure, prevent, or mitigate COVID-19. More >

Status of USP Chapter 800 Becomes More (and Less) Clear Following USP Appeals Panel Decision
By: Jennifer L. Hilliard 

On March 12, 2020, an Appeals Panel of the United States Pharmacopeial Convention (“USP”) granted appeals to revisions of two compounding standards, which has a direct effect on the applicability within the USP compendium of USP Chapter <800>. More >

Upcoming Events

Carolina Wirth to Speak at ABA’s Panel Discussion on May 13th      

Join AGG attorney Carolina M. Wirth for a panel discussion, alongside industry and other legal experts, on May 13th at 12PM EDT, titled “How Will Law Treat Science and Medicine Once the Pandemic Subsides?” Hosted by the American Bar Association’s Section of International Law, panelists will provide an overview of the current and future legal and operational challenges brought on by the COVID-19 pandemic. More >

Industry Activities and Recognition


Alan Minsk Recognized as a Leading Attorney in Life Sciences by Chambers USA 2020

    The newly released Chambers USA 2020 recognizes seven practices and 20 AGG lawyers as exceptional in their field, including Alan G. Minsk, leader of the Food and Drug Practice and co-leader of the Pharmaceuticals and Biotechnology Industry Team. To view the press release and other AGG attorneys and practices distinguished by Chambers USA, please click here.

AGG's Healthcare Practice Ranked Band 1 by Chambers USA 2020

    Chambers describes AGG’s Healthcare practice as a “Highly adept team advising on a broad range of healthcare transactional work … and also excels in FCA investigations and certificate of need disputes. [AGG] acts for clients across the healthcare sector, including healthcare systems, long-term healthcare providers and healthcare-focused private investment management firms, and frequently represents major national and multinational healthcare entities.” To view the press release, please click here.

    Alan Minsk and Genevieve Razick Named as Top Authors by JD Supra
    JD Supra’s Readers’ Choice Awards distinguishes authors whose content received a high level of reader engagement. Alan G. Minsk was recognized for his Life Sciences articles and Genevieve M. Razick was recognized for Healthcare articles. JD Supra delivers attorney content to executives, in-house counsel, lawyers, journalists, and other targeted readers. Nearly 50,000 authors have been published on JD Supra and only 235 thought leaders are selected for highest visibility and engagement for their subject matter. To view the press release and other distinguished authors, please click here.


This newsletter is published by Arnall Golden Gregory’s Food and Drug and Government Affairs and Public Policy Practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information about the Food and Drug Practice, please contact Alan Minsk.

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