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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

Podcast Episode 2: I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues

In today’s podcast entitled “Key Due Diligence Issues to Consider When Acquiring or Investing in Life Sciences Companies or Products,” AGG partners Alan G. Minsk and Brian A. Teras provide an overview of the diligence process, potential red flags, common mistakes, and other factors to consider during the due diligence process. To listen to the podcast, please click here.

Each month, we'll release a new podcast where different members of our Food and Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal issues. Last month, AGG partners Alan G. Minsk and Michael E. Burke presented on "Quality Agreements for FDA-Regulated Products: Looking Under the Hood." To listen to the podcast, please click here.

Quality Agreements: An AGG Podcast Recap
By: Alan G. Minsk and Michael E. Burke

AGG’s Food and Drug practice team launched its podcast series to discuss topics affecting the FDA-regulated industry. The series, titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues,” employs a Q&A back and forth format, lasting no more than thirty minutes. The first episode, led by AGG partners Alan G. Minsk and Michael E. Burke, focused on quality agreements. They shared common mistakes that companies make and best practices to maximize the benefit of a quality agreement. This bulletin highlights some of the issues they discussed. More >

Industry Insights

A Guide to FDA’s Final Rule on the Importation of Prescription Drugs from Canada
By: Seth S. Ray

On September 25, 2020, the Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The rule allows FDA-authorized programs to import certain prescription drugs from Canada under specified conditions designed to ensure that the imported drugs pose no additional risk to the public’s health and safety, as well as to provide a “significant reduction” in costs to American consumers. The final rule goes into effect on November 30, 2020. More >

We Have Come Full Circle: FDA Will No Longer Authorize Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China
By: Carolina M. Wirth 

On October 15, 2020, FDA reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) manufactured in China that are not approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH). Effective immediately, for emergency use, FDA will authorize only those respirators currently listed in the EUA’s Appendix A (List of Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China). The agency will continue to allow the emergency use of the respirator models that have already been added to Appendix A, in order to mitigate any current shortages of FFRs. However, the agency also stated that it would no longer “review requests nor add to the list of authorized respirators . . . .” More >

Required Revisions to Nutrition and Supplement Facts Labels are to be Fully
Implemented by January 1, 2021
 By: Robert Durkin

The Food and Drug Administration issued new regulations requiring changes to the nutrition and supplements facts labels of conventional food and dietary supplements, respectively, on May 27, 2016. Eventually, implementation dates for these new regulations were set so that manufacturers with $10 million or more in annual sales were required to switch to the new label by January 1, 2020, and manufacturers with less than $10 million in annual food sales have until January 1, 2021, to comply. FDA also announced that it intended to exercise enforcement discretion to “work cooperatively with manufacturers and will not focus on enforcement actions during 2020 for larger manufacturers and during 2021 for smaller manufacturers.” More >
Upcoming Events
Carolina Wirth and Genevieve Razick to Present at FDLI’s Introduction to Drug Law and Regulation on “Regulation of Over-the-Counter (OTC) Drugs” on November 12
AGG attorneys Carolina M. Wirth and Genevieve M. Razick will be presenting on the regulation of OTC drugs at FDLI’s Introduction to Drug Law and Regulation virtual course on November 12, 2020. For more information or to register, please click here
Alan Minsk and Carolina Wirth Named as Discussants in FDLI’s Food and Drug Law Journal 2020 Symposium

AGG Food and Drug team leader Alan G. Minsk and team member Carolina M. Wirth are named as discussants in FDLI’s complimentary Food and Drug Law Journal 2020 Symposium on November 13, 2020. Alan and Carolina will serve as commentators on the following presentations: “Updating the Federal Approach to Regulating Personal Protective Equipment” and Regulatory Reactivity: FDA and the Response to COVID-19.” For more information or to register, please click here

Industry Activities and Recognition
Robert Durkin Quoted in Articles by Food Quality & Safety and WIRED

AGG Dietary Supplements team member Robert Durkin was quoted in a Food Quality & Safety’s article - titled, “FDA Requests Guidance on Nutrition Labeling for Sugars” on October 21, 2020. Bob provided comments on the requests for nutritional labeling for non-traditional sweeteners. To read the full article, please click here.

On October 21, 2020, Bob was also quoted in a WIRED’s article - titled, “Americans Took Prevagen for Years - as the FDA Questioned Its Safety.” Bob commented on the adverse side effects of consuming Prevagen, a branded supplement. To read the full article, please click here.
Alan Minsk Interviewed by NTD News on COVID-19 Vaccine Release Date
AGG Food and Drug team leader Alan G. Minsk was interviewed by NTD News on October 16, 2020. Alan told NTD News that a pre-election vaccine for the coronavirus will not be available anytime soon. To listen to the full interview, please click here.


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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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