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 February 2020

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.

In this Issue

 Industry Insights

Rx Drug & Medical Device Advertising & Promotion – Considerations & Predictions for 2020
By: Alan G. Minsk and Seth S. Ray

AGG attorneys Alan G. Minsk and Seth S. Ray recently presented a webinar on “FDA Regulation of Rx Drug and Medical Device Advertising & Promotion: The Year in Review.” The webinar focused primarily on an in-depth review of the enforcement letters issued by FDA to prescription drug and medical device companies during 2019 concerning product promotion and other considerations and predictions for 2020. More >

FDA Issues Draft Guidance on Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products
By: Alan G. Minsk and Genevieve M. Razick

On February 3, 2020, the Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research issued jointly a draft guidance entitled, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers." More >

Not So Clean After All: FDA Takes Aim at Manufacturer of OTC Hand Sanitizer Product Line Making Disease Prevention Claims from Ebola to the Flu
By: Carolina M. Wirth

With everyone worrying about the coronavirus and the flu this time of year, it is not surprising that last month the Food and Drug Administration issued a Warning Letter against the manufacturer of a well-established over-the-counter hand sanitizer product line. According to the Warning Letter, the hand sanitizers were intended for use as consumer and healthcare antiseptics; however, FDA found that as currently formulated and labeled, the hand sanitizers were unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More >

AGG Webinar on Six Things You Need to Know about Life Sciences M&A
By: Brian A. Teras and Joel N. Gossner

We invite you to attend our March 26 webinar:Six Things You Need To Know About Life Sciences M&A.” During the webinar, we’ll share some key considerations relating to life sciences M&A. Also, in contrast to our October 2018 webinar, “Money, Money, Money: Raising Capital and Exit Transactions for Life Sciences Companies, when we covered a variety of topics at a high level, this webinar will be a deeper dive into a shorter list of topics that are specifically related to M&A transactions.  More >

Upcoming Events

AGG Partner Alan G. Minsk Will Speak at Georgia Tech 
AGG Partner Alan G. Minsk will speak at Georgia Tech School of Chemical and Biomolecular Engineering lecturing on the legal and regulatory aspects of pharmaceutical development. The presentation will be on March 10th. [Closed to the Public]

AGG Partner Alan G. Minsk Will Present at the 44th International Good Manufacturing Practices Conference
Join AGG Partner Alan G. Minsk as he presents at the 44th International Good Manufacturing Practices Conference on the "Techniques of Communicating with the Food and Drug Administration" at the University of Georgia in Athens, GA on March 12th.

AGG Partner Alan G. Minsk Will be a Panelist at the Medical Device Research & Development Summit
AGG Partner Alan G. Minsk will be a panelist at the Medical Device Research & Development Summit presenting on "Precision Medicine: U.S. FDA Legal/Regulatory Considerations” in Tel Aviv, Israel on March 24th.

AGG Attorney Robert Durkin to Speak at a Panel on CBD Regulation, Safety, Efficacy, and the Legal Landscape from Trusted Brands
Join AGG attorney Robert Durkin and officers from Papa & Barkley and KGK Science as they discuss the current CBD regulatory climate for 2020, current litigation and warning letters, and legal pitfalls on March 5 from 8:30AM – 9:30AM at Natural Products Expo West.

AGG Attorneys Brian A. Teras  and Joel N. Gossner Will Present a Complimentary One Hour Webinar 
Life sciences M&A activity soared to a new high in 2019, and we expect focused growth to continue to drive deal making activity throughout 2020. Valuations for small to mid-size life sciences companies in certain sectors have moderated, creating buying opportunities.

Join AGG attorneys Brian A. Teras and Joel N. Gossner for a complimentary webinar on March 26th as they discuss key deal terms, rep and warranty insurance for life sciences transactions, acquisitions of small and mid-cap publicly traded life sciences companies, and several other things.

AGG Attorneys Carolina M. Wirth and Genevieve M. Razick to Present at “Promotion & Advertising” at FDLI’s Introduction Medical Device Law & Regulation
Join AGG attorneys Carolina M. Wirth and Genevieve M. Razick as they present on “Promotion & Advertising” at FALI’s Introduction Medical Device Law & Regulation on April 8th at 1:00PM – 2:30PM at Arent Fox in Washington, D.C.

AGG Attorney Carolina M. Wirth to Present “Regulation of Over-the-Counter Drugs” at FDLI’s Introduction to US Drug Law and Regulation
Join AGG attorney Carolina M. Wirth as she present “Regulation of Over-the-Counter (OTC) Drugs” at FDLI’s Introduction to Drug Law and Regulation on April 16th at 11:00AM – 12:00 PM at Alston & Bird in Washington, D.C.

Industry Activities and Recognition

AGG Partner Alan G. Minsk Recognized by Lexology for Client Choice Award Winner in Life Sciences
AGG is delighted to announce that Lexology has recognized our partner Alan G. Minsk as the 2020 winner of the Client Choice award in Life Sciences in Georgia. The award focuses “on the ability to add real value to clients’ business above and beyond other players in the market.”

AGG Partners Jennifer Downs Burgar and Alan G. Minsk are Recognized by Who's Who Legal for Life Sciences
AGG Partners Jennifer Downs Burgar and Alan G. Minsk are recognized as leading lawyers in the Life Sciences – Regulatory category of Who’s Who Legal’s Global Guide. 


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.
©2020. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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