This Week at FDA: Antibiotic impurities guidance, new nitrosamine woes, and FDA’s busy calendar

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 issued new guidance on organic impurities in antibiotics and sent a letter to combination product makers alerting them to potential nitrosamine impurities in products with a drug constituent.

FDA published several draft guidances this week, including a guidance on specifications for organic impurities in antibiotics manufactured by fermentation and semi-synthesis, and a guidance on compliance policy for and information about respirators approved by the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH).

The Center for Devices and Radiological Health (CDRH) posted a letter it sent to combination product manufacturers with device components this week cautioning them about potential nitrosamine impurities after becoming aware of a 1-methyl-4-nitrosopiperazine (MNP) impurity in certain combination products containing rifampin. The letter notes that the center in unaware of any adverse events related to nitrosamine exposure from CDRH-led combination products. Nonetheless, CDRH outlines manufacturer responsibilities and lists resources to help identify and manage potential nitrosamine impurities in their products.

FDA will host a hybrid meeting on 23 June to update stakeholders on the five-year financial plans for the drug, biologics, and generics user fee programs. The agency plans to discuss its progress implementing resource capacity planning as part of fee setting and modernized time reporting.

FDA is hosting a webinar in partnership with the Duke-Margolis Institute for Health Policy on 29 April to update stakeholders on its RCT-DUPLICATE initiative, a demonstration project looking at methodological challenges in studies that use real-world data (RWD). The agency said that during the webinar, regulators would discuss how the initiative evaluates when and how non-randomized healthcare database studies have generated valid causal inferences, using randomized controlled trial findings as a benchmark.

Duke-Margolis is also co-hosting a hybrid public meeting with FDA to discuss increasing access to nonprescription drugs on 23 April. The agency is also asking for stakeholder input before the meeting.

FDA has updated several of its adverse event reporting websites informing stakeholders that starting on 14 April, the agency's new ESG NextGen Unified Submission Portal (USP) replaced its WebTrader user interface. The update comes a month after the agency announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS), which it says will modernize adverse event reporting and provide greater transparency.

FDA published several reports complying with the Food and Drug Administration Amendments Act (FDAAA) to track and publicly provide certain pediatric information resulting from pediatric clinical trials. They include information on the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) waivers, as well as CDER and CBER study progress reports and deferred studies reports.

The Oncology Center of Excellence at FDA is hosting a webinar on 6 May to discuss the critical role nurses play as frontline professionals in oncology drug development with their participation in clinical trials, research coordination, patient care, and education. The agency said the webinar will be an opportunity for frontline nurses and regulatory professionals to discuss the role nurses play in cancer treatments and how they can inform cancer treatment development, clinical trial participation, and the patient experience.

Drugs & Biologics

Travere Therapeutics' kidney drug Filspari (sparsentan) has been approved as the first treatment for reducing proteinuria in patients aged eight years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. The drug is a dual endothelin and angiotensin II receptor antagonist and is already approved to treat slow kidney function decline in adults with primary immunoglobulin A nephropathy who are at risk for disease progression.

FDA has published several meeting minutes from its ongoing negotiations with the drug and generics industry to renew the Prescription Drug User Fee Amendments (PDUFA VIII) and Generic Drug User Fee Amendments (GDUFA IV). The meeting minutes include discussions in the PDUFA VIII steering committee about subgroup discussions and GDUFA IV discussion about industry-proposed current good manufacturing practices (CGMP) compliance communication tools.

Medtech

Merit Medical has issued a Class I recall for certain of its dialysis catheters, including its 16F Dual-Valved Splittable Sheath Introducers, due to concerns that the sheath introducer may not split as intended because of a design defect. The company has sent letters to customers asking them to stop using the products and to pull them from shelves.

As part of its class I recall for its TMJ unilateral and bilateral implants due to a discrepancy in the positioning of the screw hole between what was specified in the design specification sheet and the actual fossa design, Stryker has updated its instructions for use. The company has asked users to continue monitoring patients with the implants and to contact the company if they have devices that haven't been implanted in their inventory.

Philips issued a correction for its Trilogy Evo platform ventilators as part of its class I recall, asking customers to update the devices' software, review the latest version of the user manual addendum, and stop all use of non-pneumatic nebulizers. The company issued a recall after reports that using non-pneumatic nebulizers with the ventilators may result in a discrepancy between the set tidal volume and the tidal volume the patient receives, and the obstruction alarm does not trigger within the required timeframe in some situations.

Following Medline Industries class I recall pulling its Namic Angiographic Rotating Adaptor (RA) Control Syringes and Convenience Kits containing RA Syringes from the market last week, Medical Action issued a related early alert to remove certain of its angiographic syringes included in convenience kits from the market. AVID Medical issued a similar early alert last week for angiographic syringes included in convenience kits that are part of Medline’s Namic Angiographic Control Syringes with Rotating Adaptor.