This Week at FDA: FDA announces slew of meetings, approves multiple novel treatments
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. This week FDA announced several public workshops and advisory committee meetings, approved several new products, and more.FDA has a busy summer and fall and has announced several important meetings in the coming months. In partnership with the National Institutes of Health (NIH), and the Center for Disease Control and Prevention (CDC), the agency plans to host a joint two-day virtual workshop starting 13 August to discuss developing vaccines against fungal diseases. In particular, stakeholders will talk about Valley fever (coccidioidomycosis) and several vaccine platforms in the early stages of development to fight the disease.
On the topic of vaccines, FDA published an online guide for parents and caregivers on vaccines available to children. The webpage includes a breakdown of the potential benefits and risks of vaccines, commonly administered vaccines, and answers frequently asked questions.
Drug manufacturers can volunteer to participate in the FDA's annual Experiential Learning Site Visit Program (ELSVP) starting 1 October. The Center for Drug Evaluation and Research's (CDER) Office of Pharmaceutical Quality (OPQ) plans to send staff to drug manufacturing facilities for a day or two to get first-hand experience on how the industry operates.
In a partnership with the Reagan-Udall Foundation for the FDA, FDA plans to host a public meeting at its White Oak headquarters in Silver Spring, MD, on 16 October to discuss creating a Rare Disease Innovation Hub to boost collaboration across its product centers and help develop treatments for rare diseases. During the meeting, stakeholders can give their input on what they think the proposed innovation hub should prioritize and how it can engage the rare disease community.
In another collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, FDA plans to host another workshop at its headquarters on 6 September to discuss boosting diversity in pediatric trials. To participate, stakeholders must register by 23 August.
After receiving several adverse events reports, FDA issued a consumer alert warning the public against using certain inhalants marketed to promote alertness and boost energy. The agency noted that the products are unapproved and primarily contain ammonia that could cause serious issues such as airway constriction and eye, nose, and throat irritation.
Drugs & Biologics
FDA published a draft guidance on developing treatments for bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). The draft is an update to a previous final guidance on the issue and is based on feedback the agency has received from stakeholders.
Purdue's Zurnai (nalmefene hydrochloride) has been approved as the first-of-its-kind auto-injector to treat opioid overdoses by FDA. The drug had received fast track and priority review from the agency, which had already approved it in May 2023 as a nasal spray.
Medimmune's supplemental biologics licensing application (sBLA) for its live attenuated influenza vaccine, Flumist, for the 2024/2025 flu season was approved for the US market by FDA on 6 August. The agency told the company to submit its final labeling within two weeks.
Servier Pharmaceuticals's Voranigo (vorasidenib) has been approved by the FDA to treat patients 12 and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation after surgery. The agency noted that this is the first time it has approved a systemic therapy for the disease. It reviewed the drug under its Project Orbis and granted it priority review, fast track, and breakthrough designations.
The Center for Biologics Evaluation and Research (CBER) published demographic data on new biologics approved in 2022. The 2022 Food and Drug Omnibus Reform Act (FDORA) required FDA to implement policies to increase clinical trial diversity, and the report is a snapshot of how major clinical trials have fared in achieving that goal.
CBER's 2024 Science Symposium is scheduled for September 16 to 18 at FDA's headquarters. Stakeholders will have the opportunity to discuss and learn about emerging and re-emerging diseases, advanced manufacturing and analytics, immune response to vaccination, and more.
FDA's Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee are set to have a joint meeting on 19 November to discuss the Risk Evaluation and Mitigation Strategy (REMS) requirements for the anti-psychotic drug clozapine. Experts plan to discuss possible changes to the REMS to reduce burdens on patients, pharmacies, and prescribers.
FDA's Gastrointestinal Drugs Advisory Committee is scheduled to meet 13 September to discuss whether to recommend expanding the indication for Intercept Pharmaceuticals' Ocaliva (obeticholic acid) to treat patients with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either alone or in combination with ursodeoxycholic acid (UDCA). The drug is already approved for PBC patients with advanced cirrhosis.
FDA's Antimicrobial Drugs Advisory Committee is set to meet 9 September to discuss whether to recommend Iterum Therapeutics' sulopenem etzadroxil/probenecid tablets to treat uncomplicated urinary tract infections caused by designated susceptible bacteria in adult women. The company resubmitted its new drug application (NDA) for the combination drug treatment earlier this year after the agency gave it a complete response letter (CRL) asking for more data.
Medtech
One Lambda's SeCore CDx HLA Sequencing System, a human leukocyte antigen (HLA) typing companion diagnostic, was cleared by FDA. The test can be used to diagnose unresectable or metastatic uveal melanoma before patients are treated with Kimmtrak (tebentafusp-tebn) and certain patients with unresectable or metastatic synovial sarcoma before they are treated with Tecelra (afamitresgene autoleucel).
Hologic's Aptima HIV-1 Quant Dx Assay, an in vitro nucleic acid amplification test (NAAT) to help diagnose human immunodeficiency virus type 1 (HIV-1), has been cleared by FDA. The agency noted that it is only to be performed by trained laboratory personnel in a hospital or laboratory setting.
Medtronic has issued a class I recall correcting its NIM Vital Nerve Monitoring Systems after receiving reports of false negative responses. The systems are used during surgery to locate, monitor, and stimulate cranial, spinal, and other key nerves and issue an electromyography (EMG) tone to prevent nerve damage. False negative responses where it fails to issue an EMG tone could cause severe nerve damage and potentially death.
Smiths Medical has issued a class I recall updating the software on its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pump due to a slew of problems such as alarms failing to go off when there's an upstream occlusion, unresponsive stop and power keys, no audible alarm sound, and more. The pumps are used to deliver drugs, and failing to do so could have severe consequences, including death.
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