FDA Roundup: September 15, 2023

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For Immediate Release: September 15, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA issued the draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products” and corresponding Notice of Availability (NOA). In this draft guidance, the FDA outlines its recommendations for biosimilar and interchangeable biosimilar product labeling. The FDA has now approved 42 biosimilar products, including four interchangeable biosimilars, and has gained valuable experience about labeling considerations for biosimilar and interchangeable biosimilar products. This guidance considers that experience and includes recommendations on labeling for interchangeable biosimilar products and other topics. For information on how to submit comments, please visit https://www.regulations.gov/docket/FDA-2016-D-0643
• On Thursday, the FDA issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech. These products were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped the FDA to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers.  
• On Thursday, the FDA reminded consumers in It’s a Good Time to Get Your Flu Vaccine that FDA-approved flu vaccines prevent influenza and provide important benefits. Getting vaccinated in the fall can lower your chances of getting the flu. Haven’t had your flu shot yet? It’s not too late. Every flu season is different. Your best defense against the flu is to get a vaccine every year.
• On Thursday, the FDA issued an update to the final guidance: Breakthrough Devices Program. The updates align with the actions outlined in the FDA’s Center for Devices and Radiological Health Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address health inequities. The FDA has also updated the Breakthrough Devices Program website to update the device designations data and the marketing authorizations list with information from April 1 to June 30, 2023.
• On Thursday, the FDA issued an alert to parents and caregivers about LittleOak infant formulas that are currently being voluntarily recalled by the company. The products have been sold in the U.S. illegally because the company has not submitted the required premarket notification. Premarket notifications for new infant formula are intended to demonstrate the safety and nutritional adequacy of the formula by providing the FDA the opportunity to review key information about ingredients in the product, key nutritional information, and manufacturing information, among other things, before the product is available long-term on the U.S. market. It is prohibited to introduce into U.S. commerce a new infant formula without submitting a premarket notification to the FDA. The FDA also expressed concerns that preparation instructions on the label of the LittleOak infant formula containers do not align with measurements commonly displayed on infant formula bottles in the U.S., which may pose challenges to caregivers and impede their ability to properly mix the formula at the appropriate concentration. 
• On Thursday, the FDA approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda). Project Renewal is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the selection, curation, and evaluation of evidence for independent FDA review. Project Renewal is intended to keep older, commonly prescribed oncology drugs’ labeling up-to-date, while providing transparency on FDA’s evaluation process and evidentiary standards, and improving awareness of drug labeling as an information resource. View full prescribing information for Temodar.
• On Thursday, the FDA announced the availability of draft guidance for industry that will help ensure that animal owners who are considering having their pet participate in a clinical study for a new animal drug understand the risks and benefits of their participation. Draft Guidance for Industry (GFI) #282, entitled “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals,” outlines the basic elements of informed consent in animal drug clinical studies. The FDA is accepting public comment on the draft guidance until November 14, 2023.
• On Thursday, the FDA and its regulatory counterparts in Mexico reported continued progress in strengthening food safety at the third annual executive meeting of the Food Safety Partnership September 12-13. The Acting CFSAN Director and Acting Deputy Associate Commissioner for Regulatory Affairs, led the US delegation with the goal of protecting public health through the prevention of foodborne diseases in human foods, by using modern approaches and preventive practices based on technical and scientific evidence, health surveillance, and verification measures.
• On Wednesday, the FDA granted marketing authorization to the ensoETM, a multi-lumen silicon tube intended to be inserted into a patient’s esophagus to control the patient’s temperature and to reduce the likelihood of ablation-related esophageal injury during radiofrequency cardiac ablation. The ensoETM works by connecting to compatible FDA-cleared external heat exchanger and cooling systems. It is also intended to provide gastric decompression and suctioning. This marketing authorization brings to market an additional option to prevent thermal injury during cardiac ablation procedures. 
• On Monday, the FDA published the FDA Voices: “Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy,” by: Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER) and Amy Ramanadham, PharmD, MS, Staff Director of Drug Safety Operations, CDER. Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide useful information for product labeling. The Duke-Margolis Center for Health Policy, under a cooperative agreement with the FDA, is holding a two-day public workshop on Sep. 18-19 to discuss pregnancy safety studies. At the workshop, attendees will assess the current processes to collect and evaluate postapproval pregnancy safety information and consider ways to advance this field of research to generate timely pregnancy safety data.
• This week, the FDA announced the public workshop “Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation.” The purpose of this workshop is to stimulate discussion among the FDA, academicians, and industry on endpoint and trial design to promote developing safe and effective medications without long term side effects for kidney transplantation, which is an area of unmet need. The meeting will be held Thursday, November 9 on-site and virtually. Registration is required for both online and on-site attendance. 
• This week, the FDA supported the open-ended seizure of bulk dry food products, both ready-to-eat (RTE) and non-ready to eat food products stored at Gold Coast Distributors, Inc. (Gold Coast) DBA Shah Distributors in California, based on insanitary conditions that may have resulted in the contamination of food products. The open-ended seizure includes all FDA-regulated food products stored anywhere on the property including various bulk dried lentils, beans, grains, RTE snack foods, as well as frozen food products. The firm also repacks dried beans and lentils under the Shah’s Deer brand.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

• Content current as of:

  09/15/2023