FDA Roundup: September 29, 2023

SILVER SPRING, Md., Sept. 29, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, the FDA released a video titled “Importing FDA-Regulated Products: Human Foods” that provides basic information for importers, foreign suppliers/exporters, and customs brokers on the steps they need to take to successfully import safe and compliant food into the United States.
Today, the U.S. Food and Drug Administration announced it has awarded 10 new clinical trial studies, funded by Congress through the Orphan Products Grants Program, to support the development of medical products for rare diseases. These grants will provide more than $27 million of funding to clinical researchers over the next four years.

“Millions of people in the U.S. suffer from a rare disease or condition. Currently, treatment options for many rare diseases are often limited or non-existent,” said Sandra Retzky, D.O., J.D., MPH, director of Office of Orphan Products Development. “The Orphan Products Grants Program invests in new research that will help enhance our understanding of rare diseases and advance therapies to improve the lives of those affected.”

This year the FDA received 35 grant applications for this grant program that provided proposals that would evaluate the safety and/or efficacy in support of new indications or changes in labeling to address unmet needs in rare diseases or conditions. Funded studies consisted of collaborative, efficient and innovative designs that demonstrate early and ongoing patient engagement and use of established infrastructure. This year’s funded projects involve a treatment for children with severe heart failure, an antidote for snake venom, cancer treatments and a treatment for complications linked to bone marrow transplants.

See Orphan Products Grants Program for the full list of awardees.
Today, the FDA announced it has awarded more than $16.9 million in funding over the next four years to support important research through its Rare Neurodegenerative Disease Grant Program, including studies for amyotrophic lateral disease (ALS) as well as other rare neurodegenerative diseases such as Niemann-Pick type C and myotonic dystrophy type 1. This grants program was established under the Accelerating Access to Critical Therapies for ALS Act.

“Despite ongoing advancements in research on rare neurodegenerative diseases, there remains a substantial need to support the development of safe and effective treatments,” said Sandra Retzky, D.O., J.D., MPH, director of Office of Orphan Products Development. “The FDA awards these grants to help meet critical needs for people with rare diseases.”

This year the FDA received 14 applications for this grant program. The FDA remains committed to all rare neurodegenerative diseases to promote medical product development for such diseases. See Rare Neurodegenerative Disease Grant Program for the full list of awardees.
On Thursday, the FDA released two guidance documents that outline recommendations for how sprout operations may comply with the Produce Safety Rule. The first is a guidance (2023 Final Guidance) that updates and finalizes certain sections of the January 2017 Draft Guidance entitled Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations. The second guidance (2023 Draft Guidance) re-issues certain sections of the January 2017 Draft Guidance and issues one new section for sprout operations as revised draft guidance.
On Thursday, the FDA issued a Warning Letter to Infinant Health, Inc. (formerly Evolve Biosystems) for its product, Evivo with MCT Oil, a product the company refers to as a probiotic and which contains B. longum subsp. Infantis EVC001 bacteria. The company markets the product for use in infants aged 0 to 36 months. Based on intended uses on the company’s website and Evivo with MCT Oil Product Information sheet, the product is an unapproved new drug and unlicensed biological product which was introduced or delivered for introduction into interstate commerce in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act) and Public Health Service Act. The product is also an adulterated food under the FD&C Act, because when intended for consumption by preterm infants, the use of B. longum subsp. Infantis EVC001 is an unsafe food additive. Additional details may be found in the Warning Letter.
Today, the FDA has issued a Dear Healthcare Provider (DHCP) Letter to provide important safety information to healthcare providers on the use of products containing live bacteria or yeast (commonly called probiotics) in preterm infants. The letter warns healthcare providers that preterm infants who are given probiotics are at risk of invasive, potentially fatal disease cause by the bacteria or fungi contained in probiotics. The DHCP Letter includes information about a preterm infant who was administered Evivo with MCT Oil as part of in-hospital care who developed sepsis caused by the bacterium Bifidobacterium longum and subsequently died. The DCHP letter is posted on FDA’s website.
On Wednesday, the FDA’s Center for Veterinary Medicine released its FY 2024-2028 plan for supporting antimicrobial stewardship in veterinary settings. The new plan kicks off October 1, 2023, and advances many of the key activities initiated during the previous plan (2019-2023). As the FDA develops and implements strategies to address individual actions in the plan, it will solicit public feedback on certain key initiatives. Stakeholders and the public can see what FDA has accomplished thus far and follow the agency’s progress via FDA-TRACK: Progress on FDA’s Support of Antimicrobial Stewardship in Veterinary Settings.
On Tuesday, the FDA approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed (ND) or resistant or intolerant (R/I) to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 mg and 100 mg. The most common adverse reactions in pediatric patients (≥20%) were diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. View full prescribing information for Bosulif
On Tuesday, the FDA announced the public workshop “Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients with Renal Impairment.” The purpose of the public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge and consider scientifically supported approaches to improve the current model for dosing in pediatric patients with renal impairment. The meeting will be held November 30 and December 1 both on-site and virtually. Registration is required for both online and on-site attendance.

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