WASHINGTON, D.C. — The U.S. Food and Drug Administration announced two major actions last week: making its internal drug application checklists public to improve transparency and issuing the first-ever emergency use authorization for an animal drug.
On Thursday, the FDA’s Center for Drug Evaluation and Research (CDER) released internal filing checklists used by staff to determine whether new drug and biologics applications are complete and ready for review. The move aims to reduce filing deficiencies that can delay promising treatments from reaching patients.
“Drug applications should not be derailed or delayed by preventable procedural oversights,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Making these checklists public is a common-sense step to make the FDA process easier to understand and more transparent.”
Applications submitted to CDER undergo an initial filing period in which each review division uses its checklist to ensure the submission is complete. In cases of major deficiencies, the FDA may issue a “Refuse to File” (RTF) notice, requiring companies to resubmit. Over the past decade, more than 200 applications have received RTF determinations, often delaying approval by more than a year.
“Releasing these checklists to the public helps ensure transparent, accurate and complete communication between the FDA and sponsors,” said George Tidmarsh, M.D., Ph.D., director of CDER. “We expect that this will increase efficiency by eliminating preventable RTF actions.”
The checklists were included in the latest update of CDER’s Manual of Policies and Procedures 6025.4: Good Review Practices – Refuse to File. The agency emphasized that while the documents are useful tools for drug developers, they do not replace the FDA’s legal or scientific judgment.
A day later, the FDA issued an emergency use authorization for Credelio (lotilaner), a chewable tablet developed by Elanco US Inc., to treat infestations of New World screwworm (NWS) in dogs and puppies. It marks the first time the agency has granted such authorization for an animal drug.
“The FDA acted swiftly to make a screwworm treatment available for dogs in the U.S.,” Makary said. “When it comes to emerging animal health threats, we need to be proactive, not reactive.”
Timothy Schell, Ph.D., director of the FDA’s Center for Veterinary Medicine, said the agency is reviewing additional requests for emergency use authorizations covering other animals, including livestock and wildlife.
Although New World screwworm was eradicated from North and Central America decades ago, the parasite has re-emerged since 2022 and now threatens livestock and wildlife near the U.S.-Mexico border. The Health and Human Services Secretary formally designated the outbreak a potential public health emergency in August, allowing the FDA to issue emergency authorizations for affected species.
Credelio was first approved in 2018 to treat flea and tick infestations. Lotilaner, its active ingredient, belongs to the isoxazoline class of antiparasitic drugs. While generally safe, the FDA noted potential side effects such as tremors, ataxia, and seizures in some dogs. The drug will be available only by prescription from licensed veterinarians.
The emergency authorization remains in effect until revoked or until the HHS Secretary terminates the emergency declaration.
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