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.

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FDA Issues Draft Guidance on Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products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Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research issued jointly a draft guidance entitled, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers."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 >