This Week at FDA: Califf testimony, AI/ML tools for biologic characterization, and more

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 watched FDA Commissioner Robert Califf testify before the new Congress for the first time and read about the use of artificial intelligence/machine learning (AI/ML) image analysis tools to characterize biotherapeutics.
 
On Wednesday, Califf and other top Biden administration health officials testified on the federal response to the COVID-19 pandemic. Califf was also asked about the status of the agency’s inspections program, staffing, and medical product shortages.
 
Researchers from FDA’s Center for Drug Evaluation and Research (CDER) published an article this week on artificial intelligence/machine learning assisted image analysis for characterizing biotherapeutics, specifically looking at convolutional neural networks (CNNs) to help understand certain product quality attributes. “Application of artificial intelligence/machine learning (AI/ML) in the form of CNNs has enabled processing of large collections of images with high efficiency and accuracy, by distinguishing complex ‘textural features’ which are not readily delineated with existing image processing software,” the authors write.
 
FDA’s Oncology Center of Excellence this week announced that GlaxoSmithKline’s Jemperli (dostarlimab-gxly) has received regular approval to treat adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed during or after a prior platinum-containing regimen and who are not candidates for curative surgery or radiation. The drug first received accelerated approval for the indication in April 2021.
 
Next month, FDA will host a two-day virtual public workshop on priorities for developing digital health technologies to support clinical trials for drug development. The agency said the workshop will focus on “improving participant access, increasing diversity, and facilitating engagement through remote trial-related measurements; understanding patient and industry perspectives; understanding opportunities for remote data acquisition directly from trial participants; and using DHTs to capture clinical outcomes measures.”
 
The agency also opened in-person and virtual registration for its 2023 Generic Drug Science and Research Initiative Public Workshop. The two-day workshop will take place from 11-12 May at the agency’s White Oak campus.
 
The Reagan-Udall Foundation this week announced that it has elected new officers and members to its board of directors. Richard Schilsky will serve as Chair of the foundation’s board of directors and Georges Benjamin will fill the position of vice chair. The board added three new members, including Esther Krofan of the Milken Institute, Phuong Khanh Morrow or CRISPR Therapeutics and Richard Moscicki or Moscicki Consulting.
 
Drugs & biologics
 
On Thursday, FDA updated its recently issued, immediately effective, guidance on compounding children’s oral ibuprofen products in the wake of increased demand to enable state licensed pharmacies and applicable federal facilities to dispense compounded versions of the drug with a patient-specific prescription. FDA initially issued the guidance in response to “record high demand” for pediatric ibuprofen amid the ongoing flu, COVID-19 and respiratory syncytial virus (RSV) outbreaks.
 
FDA announced this week that it is withdrawing its temporary enforcement discretion policy for repackaging or combining propofol products during the COVID-19 public health emergency (PHE) after determining that the drug is no longer in shortage.
 
The agency’s outside vaccine experts will meet early next month to make recommendations on strain selection for the 2023-2024 influenza season, FDA announced this week.
 
Reuters reports that FDA has placed a partial hold on Blueprint Medicines’ Phase 1/2 VELA trial for its investigational drug BLU-222 due to “visual adverse events (AEs) observed in a limited number of patients.” The company said that patients already enrolled in the trial will continue to receive the drug, though additional patients will not be enrolled during the hold.
 
Medtech
 
FDA on Thursday published three new safety summary reports in partnership with ECRI on materials used in medical devices. The new reports offer safety data on cobalt chromium (CoCr), stainless steel and titanium. Over the last few years, FDA has released 20 material safety summaries, including reports on common device materials such as nitinol, polyethylene terephthalate and siloxanes.
 
The agency has published new data on the medical device reports (MDRs) it has received related to the breakdown or suspected breakdown the polyester-based polyurethane (PE-PUR) foam used in Philips Respironics ventilators, BiPAP and CPAP machines subject to a class 1 recall that began in June 2021. FDA said it has now received more than 98,000 MDRs, including 346 reports of death reportedly associated with the issue. The latest batch of MDRs contained more than 8,000 reports, 82 of which reported a death.
 
FDA this week announced that three new and two updated tools have been added to its regulatory science catalog for medical device developers in areas where standards and qualified medical device development tools (MDDTs) are not available. The new tools include the color performance review tool for endoscopy devices, the human shoulder finite element model and the monopolar radiofrequency (RF) thermal dispersion model for the vaginal wall. The two updated tools are the gravity flow rate testing in enteral tubes and reusable small volume blood reservoir for in vitro dynamic hemolysis testing.
 
Universal Meditech Inc. is recalling its Skippack Medical Lab COVID-19 direct antigen rapid tests, as the tests have not been authorized, cleared or approved by FDA.