FDA Roundup: March 19, 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 provided an update on our evaluation of quality and performance issues related to plastic syringes made in China, and announced additional recommendations and actions the FDA is taking to address these issues. The FDA issued warning letters to three entities that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. The FDA expects these entities to fully address the violations described in the warning letters and will take additional steps as appropriate. We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing. This is an evolving situation, and we will continue to keep the public informed as new or additional information becomes available. 
• Today, the FDA released a podcast featuring Dr. Theresa Michele, Director of the Office of Nonprescription Drug Products at the FDA’s Center for Drug Evaluation and Research and Dr. Ilisa Bernstein, senior vice president for practice, policy and partnerships of the American Pharmacists Association discussing the FDA’s advisory committee meeting on oral phenylephrine as a nasal decongestant. The podcast was moderated by Dr. Sara Roach, a pharmacist with the Division of Drug Information at the Center for Drug Evaluation and Research. 
• On Monday, the FDA launched a new portal for patients, consumers and health care professionals to report potential drug shortage issues directly into CDER’s NextGen system without creating a NextGen account. 

  Since 2017, NextGen has been a way for regulated industry to communicate with the FDA, including submitting information on shortages, discontinuations, and anticipated supply disruptions. Non-industry stakeholders without a NextGen account previously reported information about potential shortages to the FDA’s Drug Shortages Staff by email. The new public portal allows anyone to submit shortage information through an online form directly into NextGen.  

  Expanding access to NextGen’s shortage reporting beyond regulated industry will allow for greater consistency and ease of reporting by outside stakeholders, and greater efficiency in tracking and responding to these reports. 

• On Friday, the FDA approved DuOtic (terbinafine and betamethasone acetate otic gel) for the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis). DuOtic is the first FDA-approved animal drug intended to treat yeast-only otitis externa in dogs. DuOtic is also the first otic drug intended to treat otitis externa that does not contain an antibiotic. This allows veterinarians to focus treatment and avoid using antibiotics when dogs have diagnosed yeast-only ear infections. DuOtic is only available by prescription from a licensed veterinarian.

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