This Week at FDA: New guidances, upcoming meetings and several recalls

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 released several important guidances, announced it is looking for more than a few good patient advocates, and shuttered its allergy advisory committee due infrequent action.

The US Food and Drug Administration (FDA) issued several guidances, including a guidance on what to include in premarket applications for dental curing light devices, as well as one on dental composite resin devices. The agency also published two final guidances that are high priority for its commissioner, Robert Califf: one on devices intended to treat opioid use disorder (OUD) and one on what manufacturers can do to fight misinformation about their products.

As part of its ongoing efforts to implement a rule to regulate laboratory-developed tests (LDT), FDA plans to host a webinar on 22 August to discuss how LDT manufacturers can comply with its medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements. Stakeholders can submit questions for agency officials by 22 July.

In collaboration with the Clinical Trials Transformation Initiative (CTTI), FDA is asking patient advocates to volunteer for its Patient Engagement Collaborative (PEC), which is intended to be a forum for agency staff and the patient community to discuss topics such as increasing meaningful patient engagement with diverse populations. The agency is looking for 75 volunteers and is accepting applications through 8 August.

In another collaboration with CTTI, FDA plans to host a public workshop on 6 August to discuss using artificial intelligence (AI) to develop drug and biological products.

The University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI) and FDA plan to host a one-day hybrid workshop on 6 September on how to increase pediatric clinical trial enrollment from historically underrepresented populations. Participants will discuss the challenges of pediatric clinic trial participation, how to assess diverse clinical study enrollment, and strategies to increase participation of underrepresented populations.

The University of Georgia’s International Biomedical Regulatory Sciences Program (UGA) and FDA are co-hosting the virtual 11th Annual UGA-FDA Medical Device Joint Regulatory Conference (UGA-FDA MDRC) on 21 August. The meeting is being organized by the FDA Office of Regulatory Affairs (ORA) and will give stakeholders a chance to learn about the evolving regulatory landscape and discuss some of the challenges.

The Allergenic Products Advisory Committee, which has advised FDA on treatments and diagnostics for allergies and allergic disease, was terminated 10 July and its functions were integrated into the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The agency said the committee has met infrequently in recent years and it no longer made sense to keep it operational.

Drug & Biologics

The Center for Biologics Research and Evaluation (CBER) is asking manufacturers to volunteer for their Cellular and Gene Therapies Interactive Site Tours Program that will allow officials from the FDA Office of Therapeutic Products (OTP) to gain first-hand knowledge about how such facilities operate. The agency attempted to alleviate manufacturer concerns that the tours would not serve to inspect the facilities but rather allow open dialogue between its officers and industry.

CBER published an updated Standard Operating Policy and Procedure (SOPP) manual for staff reviewing investigational new drug (IND) applications. Among the changes, the updated guidance details procedures for cross-referencing inactive INDs.

The biologics office plans to host two meetings to allow patients with rare diseases and their caretakers to provide feedback on issues related to gene therapy products, including their short-term and long-term risks, information that can help in their decision-making, and considerations for post-market studies. The first of the meetings is scheduled for 20 September.

FDA issued a consumer medication health fraud alert for Vail-Bon Jie Yang Wan, which is sold online to treat several skin conditions. The agency noted that it has found dexamethasone and chlorpheniramine in the product even though they are not listed on the label and could lead to complications such as impaired ability to fight infections and drowsiness.

FDA issued a consumer medication health fraud alert for Gold Hard Steel Plus, sold online for sexual enhancement. The agency found it includes sildenafil, the active ingredient in Viagra, and could cause severe drug-drug interactions.

The Genetic Metabolic Diseases Advisory Committee is scheduled to meet on 2 August to discuss and advise FDA on Zevra Denmark's new drug application for arimoclomol to treat patients 2 years and older with Niemann-Pick disease type C.

Medtech

Philips updated use instructions as part of its class I recall for its SENSE XL Torso (1.5T and 3.0T) radiofrequency coils, which are used to image patients' torsos and abdomens. According to FDA, the recall was due to concerns that the coils may heat during MRI scans and burn patients, and so far, there have been 12 reported injuries.

Philips also updated use instructions as part of their class I recall for their BiPAP V30, BiPAP A30, BiPAP A40 ventilators due to a faulty alarm that may cause treatment interruption, according to FDA. The company said if the patient tolerates treatment interruption, they should be switched to another device. Otherwise, they are asked to find an alternative ventilation solution and contact the supplier to find an alternative device.

Inspire Medical initiated a class I recall for its Inspire IV Implantable Pulse Generator (IPG), which is used as part of its Inspire Upper Airway Stimulation (UAS) system to address obstructive sleep apnea. FDA noted that the company has found manufacturing defects that could cause the implants to malfunction and require revision surgery.

Healthcare providers have been warned by FDA to stop using Medtronic's NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes. The neural integrity monitor (NIM) electromyogram (EMG) endotracheal tubes are used to provide airway ventilation to patients during surgery, but the agency noted the company is recalling the products after reports of the devices failing.

Healthcare providers should consider conservation strategies to prioritize the use of blood culture media bottles and preserve supplies for the highest-risk patients due to recent supply issues, according to FDA. Some of the strategies recommended include performing blood culture collections only when medically necessary, prioritizing patients with symptoms of bloodstream infections, and ensuring proper blood volume is collected the first time to avoid resampling blood from patients.

Hamilton Medical has issued recommendations on what to do if their HAMILTON-C6 Medical Ventilators used to help patients breathe fail to restart ventilation after it goes into sensor fail mode after open suction is performed, according to FDA. The company issued a class I recall a few months ago advising patients to update their software, and the latest alert gives instructions on how to mitigate issues if the problem persists.

This Week at FDA: New guidances, upcoming meetings and several recalls

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