This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, 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, the acting FDA commissioner wrote an op-ed promoting the agency’s efforts to incentivize domestic drug manufacturing, FDA announced new grants for using digital health technologies (DHT) for drug development, and it approved an over-the-counter combination of two popular pain drugs.

Acting FDA Commissioner Kyle Diamantas published an op-ed on Fox News's website touting the agency's PreCheck Pilot Program to onshore drug manufacturing, create domestic jobs, and secure the drug supply chain. He also discussed draft regulations to streamline drug manufacturing and increase transparency regarding foreign drug suppliers, and efforts to bring clinical trials to the US through Operation TrailBlazer.

The consumer advocacy group Public Citizen filed a petition to ban direct-to-consumer prescription drug advertising. The group said banning such ads would align with international best practices, protect the public, and promote rational and evidence-based prescribing.

FDA announced a grant for applicants who want to research how digital health technologies (DHT) can be used in drug development. Besides advancing the use of DHT in drug development, the agency said it is also intended to examine how the technology can be used to detect early manifestations of chronic diseases, determine outcomes in populations with unmet medical needs, and enhance clinical trial participation by enabling remote data acquisition.

On that theme, the Duke-Margolis Institute for Health Policy and FDA are co-hosting a virtual workshop on 27 August on using DHTs in drug development and regulatory review. The workshop will allow attendees to discuss how to strengthen data standards and develop innovative analytical methods to yield clinically meaningful, digitally derived endpoints in clinical trials for drug and biologic development.

FDA will host a virtual workshop on 27 August to discuss the latest developments and regulatory requirements when using Model-Integrated Evidence (MIE)-supported generic drug development. The agency said that attendees will learn about its regulatory expectations for MIE submissions, strategies to avoid common pitfalls, and real-world case studies on how it has been used to obtain generic drug approvals.

The Center for Research on Complex Generics (CRCG) and FDA are co-hosting a two-day hybrid workshop to discuss product development and regulatory considerations for generic glucagon-like peptide-1 (GLP-1) agonists. The workshop is intended to provide insights into topics such as synthetic and recombinant manufacturing, analytical characterizations, oral peptide formulation development, device user interface and human factors, and device quality and integration.

FDA issued an order repealing the color additive regulation that allows the food dye Orange B to be used for casings or surfaces of frankfurters and sausages. The agency said the use of Orange B has been abandoned by the food industry, and therefore, the regulation is outdated and unnecessary.

On Similar reasoning, FDA also proposed an order repealing the color additive regulation allowing Citrus Red No. 2 to color the skins of mature oranges. The agency said certification data shows that the food dye has not been certified in the US since 2020 and appears to have been abandoned by the food industry.

The National Institute of Standards and Technology (NIST) is hosting a symposium on 24 September to discuss what medical measurements and consensus standards should be prioritized to support healthcare in the US. The agency said the focus will be on identifying social and economic benefits of improved measurements and standards for medical imaging, medical devices, and diagnostics.

Drugs & Biologics

Kenvue's combination drug Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg tablets) has been approved as the first fixed-dose combination of the two popular pain relief drugs and is intended to work for up to 12 hours. The over-the-counter drug is indicated for temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor arthritis pain in patients 12 years and older.

FDA published its "Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products with Accelerated Clinical Development," which is part of its Prescription Drug User Fee Amendments (PDUFA VII) commitments. In the document, the agency said it will stop accepting new applications to its CMC Development and Readiness Pilot (CDRP) at the end of April 2027, but investigational new drug (IND) applications that were previously accepted in the pilot will continue to be in the program.

Nuvalent's Jideytro (zidesamtinib) was approved to treat patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI). FDA noted the drug received orphan drug designation and was reviewed under its Real-Time Oncology Review (RTOR) pilot program.

FDA has extended the comment period deadline for stakeholder feedback on its expedited investigational new drug pilot program until 24 August. The docket was originally set to close on July 22, and so far, it has received only 9 comments.

Medtech

Baxter has issued a letter to customers to remove certain Duo-Vent solution sets from the market due to concerns that air bubbles may form in the product's drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position. FDA issued an early alert for the products, noting that patients with certain cardiac or vascular conditions who use the faulty products may suffer from serious adverse events such as stroke, myocardial ischemia, or death.

Dexcom has been chosen as the first participant in FDA’s Technology-Enabled Meaningful Patient Outcomes (TEMPO) for digital health devices pilot that the agency has developed with the Centers for Medicare and Medicaid Services (CMS) Innovation Center (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS). The pilot allows the agency to work with manufacturers to determine when it will exercise enforcement discretion on certain product requirements to promote wider access to digital health products.

Since May, FDA has been testing consolidating its electronic medical device report (eMDR) system with its Adverse Event Monitoring System (AEMS). This week, the agency announced that the testing phase is complete and it will deploy the new system on 27 July.

Several devices were classified as class II devices, including intraoperative surgical angle measurement tools. FDA said that, as part of the required mitigation measures, the devices must undergo non-clinical performance testing, biocompatibility evaluation, sterilization and reprocessing validation, shelf-life testing, meet labeling requirements, and more.

Similarly, over-the-counter tests to detect SARS-CoV-2, diabetes digital behavioral therapeutic devices,  prognostic tests to assess chronic kidney disease progression, non-medicated topical formulations to treat erectile dysfunction, and active noise attenuation systems for infant incubators were also classified as class II devices with special controls.

FDA published a final guidance for sponsors submitting 510(k) premarket notification submissions for hemodialysis blood tubing sets. The agency said it is intended to promote consistency and allow efficient review of the devices.

After allowing the Peripheral and Central Nervous System Drugs Advisory Committee's charter to expire without renewal on 4 June, FDA said the advisory committee is being reestablished on 30 July for a span of two years. It will consist of six core voting members who will be invited to serve up to four years or less at the discretion of the FDA commissioner.