This Week at FDA: Senate user fee markup, Novavax briefing docs, and CDRH withdraws a PHE guidance

Regulatory NewsRegulatory NewsThis Week at FDAThis Week at FDA | 03 June 2022 |  By 

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, we learned that the Senate Health, Education, Labor & Pensions (HELP) committee will markup its version of the FDA user fee reauthorization bill next week. We also got a glimpse at the briefing documents for FDA’s upcoming advisory committee meeting to review Novavax’s COVID-19 vaccine. Plus, we saw FDA’s device center move to withdraw one of its pandemic-era guidances on the impact of COVID-19 on formal meetings and user fee applications for medical devices.
Next Wednesday, the Senate HELP committee will hold an Executive Session to markup its version of the FDA user fee reauthorization package, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. The markup comes just weeks after the House Energy & Commerce Committee voted to advance its user fee bill to the House floor for consideration.
FDA reviewers have found the Novavax vaccine to provide a “reduction in the risk of mild to severe COVID-19 occurring at least 7 days after the second primary series vaccination,” ahead of the Vaccines and Related Biological Products (VRBPAC) meeting on Tuesday. The reviewers also flagged a possible risk for myocarditis among recipients of the vaccine. STAT and Reuters have more on the briefing documents.
On the topic of COVID-19 vaccines, Pfizer and BioNTech have reportedly 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 in late April.
FDA also issued a notice this week that it was withdrawing a guidance first issued in June 2020 that gave sponsors an extra 180 days before automatically withdrawing their premarket application. At the time, the agency said due to the COVID-19 pandemic it was relaxing requirements to give sponsors more time, but as the pandemic has started to ease, FDA has decided it needs to return to the pre-pandemic state of affairs.
We’re also reading this interview in Politico Nightly with Brad Kimberly, FDA’s social media director, 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-heavy” and “complicated messages” in a sometimes humorous or lighthearted manner.
Plus, we learned that federal investigators will be reviewing 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 has led to critical shortages of infant formula nationwide and prompted action by the Biden administration and FDA to improve the supply of infant formula.
Drugs & biologics
This week, we saw two new warning letters sent to firms concerning deviations from human cells, tissues and cellular and tissue-based products (HCT/Ps) regulations and drug registration and listing issues. FDA’s lengthy warning letter to OsteoLife Biomedical I LLC cites numerous issues related to the company’s processing of HCT/Ps that could post a risk for contamination or cross contamination of its products or equipment. The agency also warned Grimann S.A. de C.V. for submitting “contradictory information between the labeling and the electronic listing file” for its product Derofen Miel (NDC 81660-435).
We’ve also now seen three responses to FDA’s notices of noncompliance for submitting clinical trial information to The agency has sent four notice of noncompliance letters to trial sponsors informing them of their duty to submit clinical trial results to the online repository, and the letters appear to be having an impact, as the agency has absolved the first three sponsors it has written to of any concerns.
Medical devices
This week, FDA issued a cybersecurity alert for a slew of Illumina next generation sequencing instruments. The agency said that a vulnerability in the devices could allow malicious hackers to remotely take control of the diagnostic products, change how the products work and potentially alter patient data. Illumina has issued a patch for the devices and is working with the agency and the Cybersecurity and Infrastructure Security Agency (CISA) to continue to fix the problems.
Earlier in the week, the top two officials at the Center for Devices and Radiological Health (CDRH) gave an update on how the center has fared during the pandemic and the fact they are starting to get back to some normalcy. They noted that as of 1 June, CDRH will be accepting all non-COVID-19 in vitro diagnostic pre-submissions that were put on hold so the agency could allocate resources to the pandemic.
FDA also moved to classify two types of medical devices into class II (special controls). The two device types include nonimplanted electrical stimulation devices for management of premature ejaculation and coronary artery disease risk indicators that use acoustic heart signals.
Additionally, FDA announced a Class I recall of Atrium Medical Corporation’s iCast covered stent due to potential balloon or catheter hub separation. The agency said the recall affects nearly 70,000 devices in the US and that it has received 75 complaints of injuries related to the issue.
Speaking of recalls, MedtechDive took a look at FDA’s first quarter device recalls, which surged largely due to BD’s massive recall of its catheter port connectors, which affected some 288 million devices.


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