This Week at the FDA: Senate User Fee Increase, Novavax Briefing Papers, and CDRH Withdraw PHE Guidance

Welcome to another episode of This Week at FDA, your weekly source for updates — big and small — about the FDA, drug and medical device regulation, and what we read on the web. This week, we learned that the Senate Committee on Health, Education, Labor, and Pensions (HELP) will annotate its version of the FDA user fee reauthorization bill next week. We also got a preview of briefing materials for the upcoming FDA advisory committee meeting to review Novavax’s COVID-19 vaccine. Additionally, we’ve seen the FDA’s Device Center withdraw one of its pandemic-era guidance on the impact of COVID-19 on formal meetings and user fee requests for devices. medical.

Next Wednesday, the Senate HELP Committee will meet hold an executive session to tag his version of the FDA user fee reauthorization package, the Food and Drug Administration Safety and Historic Advancements Act (FDASLA). The markup comes just weeks after the House Energy and Commerce Committee voted to bring forward its House Upstairs User Fee bill for review.

FDA reviewers found the Novavax vaccine offered a “reduced risk of mild to severe COVID-19 occurring at least 7 days after the second round of primary vaccinations”, ahead of vaccines and related biologics (VRBPAC) Meet tuesday. The reviewers also flagged a possible risk of myocarditis in vaccine recipients. STAT and Reuters learn more about the information documents.

On COVID-19 vaccines, Pfizer and BioNTech have would have have completed their Emergency Use Authorization (EUA) request to expand the use of their mRNA vaccine to children 6 months to 4 years of age, following Moderna’s similar request submitted end of April.

The FDA also issued a notice this week stating that it was withdraw an orientation first released in June 2020 which gave sponsors an additional 180 days before automatically withdrawing their premarket request. At the time, the agency said that due to the COVID-19 pandemic, it was relaxing requirements to give sponsors more time, but as the pandemic began to abate, the FDA decided that she had to return to the pre-pandemic situation.

We also read this interview in Night policy with FDA Social Media Director Brad Kimberly on some of the agency’s tweets during the pandemic. It’s an interesting look at how the agency approaches public communication on health issues, many of which are “science-intensive messaging” and “complicated messaging” in ways that are sometimes humorous or light.

Moreover, we learned that federal investigators will examine the FDA’s response to the infant formula crisis that stemmed from Abbott Nutrition’s infant formula recall following an inspection of its Sturgis, Michigan facility earlier this year. The recall led to critical infant formula shortages across the country and prompted the Biden administration and the FDA to act to improve the supply of infant formula.

Medicines and biologicals

This week we saw two new warning letters sent to companies regarding deviations from Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) regulations and registration and registration issues. registration of drugs. The FDA is long warning letter to OsteoLife Biomedical I LLC cites numerous issues with the company’s processing of HCT/P that could pose a risk of contamination or cross-contamination of its products or equipment. The agency too warned Grimann SA de CV for submitting “conflicting information between the labeling and the electronic registration file” for its product Derofen Miel (NDC 81660-435).

We also saw three responses to FDA requests notice of non-compliance to submit clinical trial information to The agency sent four letters of notice of non-compliance to trial sponsors advising them of their obligation to submit clinical trial results to the online repository, and the letters appear to be having an impact, as the agency absolved the three first sponsors she wrote to. of any concerns.

Medical equipement

This week, the FDA released a cybersecurity alert for a multitude of Illumina next-generation sequencing instruments. The agency said a vulnerability in the devices could allow malicious hackers to remotely take control of diagnostic products, change how the products work, and potentially alter patient data. Illumina has released a patch for the devices and is working with the agency and the Cybersecurity and Infrastructure Security Agency (CISA) to continue to resolve the issues.

Earlier in the week, the two top officials from the Center for Devices and Radiological Health (CDRH) gave an update on how the center fared during the pandemic and the fact that they are starting to return to some normalcy. They noted that starting June 1, CDRH will be accepting all non-COVID-19 in vitro diagnostic pre-submissions that have been put on hold so the agency can allocate resources to the pandemic.

The FDA has also decided to classify two types of medical devices in Class II (special controls). Both types of devices include non-implanted electrical stimulation devices for the management of premature ejaculation and coronary heart disease risk indicators that use acoustic heart signals.

Additionally, the FDA announcement a Class I recall of the stent covered by Atrium Medical Corporation’s iCast due to potential balloon or catheter hub separation. The agency said the recall affected nearly 70,000 devices in the United States and it had received 75 injury complaints related to the issue.

Speaking of reminders, MedtechDive reviewed the FDA’s first-quarter device recalls, which rose largely due to BD’s massive recall of its catheter port connectors, which affected some 288 million devices.

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