This Week at FDA: eCTDv4.0, data integrity warnings, and more

This Week at FDAThis Week at FDA | 13 September 2024 | Michael Mezher

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 its support for eCTDv4.0 in electronic submissions to its drug and biologics centers, the agency warned two Chinese testing firms for data integrity violations, and the National Academies has released a report calling on FDA to improve information sharing and collaboration to increase orphan drug approvals.
 
FDA on Friday said it will support the latest version of the electronic common technical document (eCTDv4.0) in electronic submission to the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The agency said it plans to update its Data Standards Catalog to add eCTDv4.0 upon publication of its notice in the Federal Register and noted that it will continue to support submissions using eCTDv3.2.2 for a period of time before dropping support in favor of the newer version. Additionally, FDA revised its guidance on regulatory submissions in electronic format to account for eCTDv4.0 support.
 
This week, FDA issued warning letters to Chinese nonclinical testing laboratories Mid-Link Testing Company Ltd and Sanitation & Environmental Technology Institute of Soochow University Ltd. The agency said that both firms provide third-party testing and validation services to medical device manufacturers. Both firms were inspected earlier this year and have been warned over “pervasive failures with data management, quality assurance, staff training and oversight.”
 
The National Academies of Sciences, Engineering, and Medicine released a report on Thursday detailing recommendations to boost the approval of rare disease therapeutics. Congress required FDA to fund the report in 2022, and the report finds that information sharing, collaboration between FDA and patients/sponsors, collaboration with the European Medicines Agency (EMA), and advancing regulatory science could “increase the pace and volume of drug approvals for rare diseases.”
 
In an update to the news last week that FDA would be looking into concerns raised about the presence of toxic metals found in tampons, FDA has issued a statement addressing its planned actions and some of the limitations of the initial 2024 study by researchers at Columbia University, University of California Berkeley, and Michigan State University that observed metal(oids) in 24 different tampon products sold in the US, EU, and UK.

FDA points out that, “While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use.” The agency said it has commissioned an independent literature review and will complete an internal bench laboratory study to evaluate the potential risks.
 
Drugs & biologics
 
CDER’s Office of Prescription Drug Promotion (OPDP) has sent an untitled letter to AbbVie concerning a direct-to-consumer television ad featuring tennis star Serena Williams for its migraine drug Ubrelvy (ubrogepant). FDA said the ads “misleadingly suggest that Ubrelvy will provide a greater treatment benefit to patients suffering from migraine headaches than has been demonstrated.” FDA also stated that Williams’ celebrity status “increases the potential for audiences to find the misleading promotional communication more believable due to the perceived credibility of the source.”
 
The Wall Street Journal reported this week that Sens. Dick Durbin (D-IL) and Mike Braun (R-IN) have proposed legislation that would enable FDA to warn and impose fines on telehealth companies and influencers who make misleading claims about drugs on social media. The senators say the legislation is in response to misleading claims about weight-loss drugs that have proliferated on social media in recent years.
 
FDA has issued a safety communication to alert patients and healthcare professionals to a new warning about a rare but potentially serious risk of liver injury with the use of Veozah (fezolinetant), which is used to treat hot flashes that occur due to menopause. FDA is advising patients to stop taking the medicine if they have any signs or symptoms of liver injury.
 
On Thursday, FDA announced it has approved Genentech’s Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for subcutaneous injection for the same adult indications as the intravenous formulations of the Tecentriq, which include non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS).
 
Medtech
 
FDA announced that its General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will meet on 7 November to review a de novo request for IceCure Medical’s ProSense Cryoablation System.
 
On Thursday, FDA said it has authorized Apple’s AirPods Pro hearing aid feature as the first over-the-counter hearing aid software. ““Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss,” said Acting CDRH Director Michelle Tarver.
 
The agency has also issued classification orders for several medical devices, placing the devices into class II (special controls), including clozapine test systems, devices to detect or measure nucleic acid from viruses associated with head and neck cancers, whole exome sequencing constituent devices, and pediatric continuous renal replacement therapy systems.
 
FDA has recognized three ISO standards related to medical device sterilization: ISO 11737-3:2023 Microbiological methods, ISO 11140-1:2014 Chemical indicators, and ISO 13004:2022 Radiation – Substantiation of selected sterilization dose. “By promoting the techniques in these international standards, the FDA is facilitating the adoption of sterilization of medical devices, enhancing quality, and advancing international harmonization,” FDA said.

 

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