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
|Not So Fast... New Guidance on the Development of COVID-19 Drugs and Biological Products Makes Clear that FDA Will Not Grant Emergency Use Authorization for Most Therapies
|By: Carolina M. Wirth
|The Food and Drug Administration has the difficult task of trying to balance the urgent need for therapeutics for the treatment of the Coronavirus Disease 2019 (COVID-19) with protecting the public health. While the agency has moved fairly quickly, with various degrees of success when it comes to diagnostics, personal protective equipment and ventilators, FDA has taken a more measured approach with drugs and biological products. More >
|Competitive Generic Therapies: FDA Issues Final Guidance
|By Alan G. Minsk and Seth S. Ray
|The FDA Reauthorization Act of 2017 (FDARA) created a new pathway to incentivize the development of generic drugs where there is inadequate competition. Under this new pathway [new Section 506H of the Federal Food, Drug, and Cosmetic Act (FDC Act)], FDA may, at the request of an applicant, designate a drug with “inadequate generic competition” as a Competitive Generic Therapy (CGT). At the request of an applicant, FDA may also expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT. We will summarize the key points from the guidance in this Bulletin. More >
|FDA Assists with the Voluntary Recall of a CBD Containing Product
|By: Robert Durkin
|On May 15, 2020, the Food and Drug Administration (FDA or “Agency”) announced a voluntary recall of a CBD containing product that tested positive for lead.1 According to information shared by FDA, the recalling firm is inspected and licensed under the Florida Department of Food and Agriculture and Consumer Services (FDFACS) to produce products containing CBD. A random sample of one of the company’s products was tested by FDACS and was found to contain lead levels at 4.7 ppm. Following the findings by FDFACS the company also had a sample of the product tested at an ISO-accredited lab. The results listed the lead content at 0.5ppm, putting it within the legal limits in Florida. However, the company initiated a voluntary recall of the implicated batch of product. More >
|Alan Minsk to Speak at “Challenges and Opportunities When Communicating with the U.S. Food and Drug Administration”
|AGG partner and leader of the Food & Drug practice team Alan G. Minsk will be speaking at a webinar titled, “Challenges and Opportunities When Communicating with the U.S. Food and Drug Administration,” on June 18, 2020. The program is sponsored by Invest Northern Ireland. For more information, please contact Alan.
|AGG Attorneys to Present “Medical Device Promotion and Advertising” at FDLI/CDRH’s Introduction to Medical Device Law and Regulation Course [Closed to Public]
|AGG attorneys Carolina M. Wirth and Genevieve M. Razick will present an in-house training course titled, “Medical Device Promotion and Advertising,” at FDLI’s Introduction to Medical Device Law and Regulation event on June 26, 2020 to FDA employees. Carolina and Genevieve will provide an overview of the FDA rules and regulations on medical device promotion and advertising. For more information, please contact Carolina or Genevieve.
|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.