FDA Roundup: June 21, 2024

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

• Today, the FDA published final guidance titled Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection. This guidance defines the types of behaviors (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of section 501(j) of the Federal Food Drug & Cosmetic Act. The examples used in this guidance are not intended to serve as an exhaustive list; rather, they illustrate the most common situations that FDA has encountered in preparing for and conducting drug or device inspections as well as situations that FDA anticipates may occur. FDA does not interpret the four terms describing prohibited behavior (delay, deny, limit, refuse) necessarily to be mutually exclusive.
• On Thursday, the FDA issued final Guidance for Industry #278, Human User Safety in New and Abbreviated New Animal Drug Applications, to clarify the current approaches and the FDA’s recommendations for Human User Safety (HUS) assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval. The guidance is intended for sponsors interested in pursuing the approval, or conditional approval, of new animal drugs (including new generic animal drugs) and is also intended for veterinary health professionals and the general public interested in understanding the general principles of HUS assessment for new animal drugs. 
• On Thursday, the FDA approved an application for Trimeprazine with Prednisolone Tablets, which is the first generic of the animal drug Temaril-P. This generic version is recommended for the relief of itching regardless of cause. It is also indicated for adjunctive therapy in various cough conditions of dogs, including for the treatment of “kennel cough” or tracheobronchitis, bronchitis including all allergic bronchitis, and infections and coughs of nonspecific origin. It will be available by prescription only. The application is sponsored by ZyVet Animal Health, Inc. 
• On Thursday, the FDA announced a recall initiated by Cardinal Health related to the Jiangsu Shenli Medical Production Co Ltd. recall to stop using its unauthorized plastic syringes. Cardinal Health recalled affected kits that contain Merit Medical kits with Jiangsu Shenli syringes. The FDA recommendations have not changed. We will continue our efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.
• On Thursday, the FDA announced a new web page and virtual public meeting dedicated to the Home as a Health Care Hub initiative. The new web page offers more detail about the initiative’s goals and background. It answers frequently asked questions, and it’s where the FDA will share progress. The FDA will hold a virtual public meeting on July 25, 2024, from 12 to 4 p.m. ET (registration required) to provide information about the initiative, seek input from stakeholders, and start a dialogue about barriers and opportunities associated with making the home part of the health care system.  
• On Tuesday, the FDA updated the advisory for the investigation of illnesses linked to Diamond Shruumz-brand Chocolate Bars, Cones, & Gummies. As of June 17, 2024, a total of 26 illnesses have been reported from 16 states. Twenty-five people have reported seeking medical care; 16 have been hospitalized. No deaths have been reported. Consumers should not eat, sell, or serve any flavor of Diamond Shruumz-brand Chocolate Bars, Cones, or Gummies, and should discard them. The FDA will provide updates as additional information becomes available.

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