This Week at FDA: CNPV vouchers for psychedelics, progress on animal testing reduction, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The US Food and Drug Administration (FDA) made several announcements related to its new drug voucher program, highlighted efforts to reduce animal testing, and more.

FDA issued vouchers under the Commissioner’s National Priority Voucher Program (CNVP) to three companies studying serotonin-2A agonists and related products, a class of perception-altering psychedelic medications. They include psilocybin for treatment-resistant depression and major depressive disorder, and methylone for post-traumatic stress disorder. The agency said that following receipt of an investigational new drug (IND) submission, it is allowing an early-phase clinical study of noribogaine hydrochloride, a psychoactive indole alkaloid, to treat alcohol use disorder. FDA noted that it plans to issue a final guidance on the topic soon as a response to an executive order to accelerate access to treatments for patients with serious mental illness.

Regeneron Pharmaceuticals’ Otarmeni (lunsotogene parvec-cwha) was approved under the CNPV pilot program as the first dual adeno-associated virus (AAV) vector-based gene therapy for patients with severe-to-profound sensorineural hearing loss associated with molecularly confirmed biallelic variants in the OTOF gene. The agency noted that it was approved 61 days after the company filed a biologics license application (BLA) and is the sixth product approved under the voucher program.

In more CNPV news, FDA announced this week that it was rescheduling a public meeting to discuss the CNPV pilot program. The hybrid meeting that was originally scheduled for 12 June will now be held on 4 June.

One year into efforts to reduce animal testing, FDA announced it has achieved its key objectives, including new draft guidance, other updated guidance, the first artificial intelligence-based drug development tool, and a new database outlining when alternative methods are acceptable.

FDA is hosting its annual hybrid Regulatory Education for Industry (REdI) Conference on 19-20 May. The agency said the meeting will give stakeholders a chance to learn from its experts about how it regulates medical products, to provide a basic foundation on its regulatory requirements, and to update them on its current activities.

The Center for Devices and Radiological Health (CDRH) published the latest meeting minutes with non-industry stakeholders such as the American Academy of Pediatrics (AAP), the National Organization for Rare Disorders (NORD), the Personalized Medicine Coalition (PMC), and Public Citizen, as they negotiate the next Medical Device User Fee Amendments (MDUFA VI) program. The agency said stakeholders requested more information on IT tools, the Total Product Lifecycle Advisory Program (TAP), digital health, continuous process improvements for premarket review, international fees, trigger reform, the use of real-world evidence (RWE), and more.

CDRH classified several products as class II devices with special controls this week. They include digital therapy devices for amblyopia, Alzheimer's disease pathology assessment tests, setmelanotide eligibility gene variant detection systems, and devices for sleep apnea testing based on mandibular movement.

Drugs & Biologics

FDA has published its congressionally mandated annual FY 2024 report on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. It details the status of studies and clinical trials that applicants are required to conduct or have agreed to conduct.

Medtech

The MITRE Corporation published a discussion paper on general cybersecurity considerations for the design of medical devices. The paper considers three specific cybersecurity issues in the context of medical device design, including cloud computing, artificial intelligence and machine learning (AI/ML), and post-quantum cryptography (PQC).

MITRE also published a white paper outlining what manufacturers should consider when developing software bill of materials (SBOM) as part of their premarket applications. The organization says the paper specifically discusses approaches to address data normalization challenges.

Following Medline Industries’ class I recall, pulling its Namic Angiographic Rotating Adaptor (RA) Control Syringes and Convenience Kits containing RA Syringes from the market two weeks ago, Aligned Medical Solutions issued a related recall to remove Namic Angiographic Rotating Adapter 10CC control syringes from its AMS6908E and AMS6908F angio packs. The announcement comes after Medical Action and AVID Medical issued similar alerts for their respective convenience kits.

Omnicell has issued an early alert for its i.v.STATION automation device after receiving a report regarding mislabeling that could affect sterile syringe labels produced using devices. The company said it has identified inconsistent label detection behavior across i.v.STATION printers using the sterile labels in question, which could result in unlabeled or mislabeled syringe preparations after compounding is complete.

Arrow International also issued an early alert for its dialysis catheter kits containing Merit Medical's 16F Dual-Valved Splittable Sheath Introducers that were part of a class I recall more than a week ago. The company has warned users not to use the Merit Medical sheath introducers that come with its Arrow International kits and sets.