This Week at FDA: Regulators publish guidances, announce meetings, ask for clinical trial feedback

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 agency published several guidances, announced key upcoming meetings and asked for stakeholder feedback on conducting clinical trials.

After a bit of a lull the past few weeks, the US Food and Drug Administration (FDA) went on another guidance publishing spree this week. It published seven medical product guidances covering topics such as developing antimicrobial drugs to treat diabetic foot infections, testing products that use pharmaceutical alcohols, developing COVID-19 vaccines, and remote monitoring devices.

FDA also announced plans to host a public webinar on its plan to implement a rule that would phase out its regulatory enforcement discretion of laboratory-developed tests (LDT). During the 31 October event, agency officials will describe their plan to start regulating certain LDTs, but perhaps most importantly, will answer stakeholder questions about the proposed rule.

As part of that plan, Medtech Insight reported that the agency expects third-party reviewers will be able to handle half the LDT product applications that come to it for premarket review.

The Center for Drug Evaluation and Research (CDER) is asking its own experts as well as external stakeholders about innovation in clinical trial designs and conduct. FDA's drug center said it wants to understand what barriers researchers face when trying to use innovative methods for conducting drug trials.

FDA, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada plan to hold a joint three-day public workshop in February 2024 to discuss good clinical practices and pharmacovigilance compliance in the post-pandemic era. More specifically, regulators will talk about updates to global good clinical practice standards for clinical trials, and new approaches to conduct trials and regulatory inspections.

STAT News reported on a study that found not including obese patients in clinical trials leads to manufacturers and healthcare providers being unsure about the efficacy of drugs on such patients. The researchers argue that FDA should require obese patients to be included in clinical trials as a precondition for approving drugs.

STAT News columnist Adam Feuerstein said FDA should step in to stop Cassava Sciences’ clinical trial of the Alzheimer’s drug simufilam. He noted that according to a report from City University of New York (CUNY), the company's principal scientific collaborator, Hoau-Yan Wang, refused to provide original data and primary research records to prove that the trial data hadn't been faked.

FDA is hosting a webinar on 28 November to discuss its recent guidance on using the Identification of Medicinal Products (IDMP) standards developed by the International Organization for Standardization (ISO). The set of five standards is meant to help regulators identify medical products around the world and electronically standardize their data.

AgencyIQ spotted a notice that the White House has cleared a Q&A guidance on “Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Certain Legally Marketed Medical Products.” Promoting off-label use of medical products is a contentious issue and will likely receive a lot of industry attention when the guidance is eventually published.

On Capitol Hill, chemical industry and medtech lobbyists went before the House Energy and Commerce Committee (E&C) to warn lawmakers that new rules from the Environmental Protection Agency (EPA) to increase regulatory oversight of ethylene oxide (ETO) used to sterilize medical devices could lead to “disastrous” consequences for patient access to medical devices. On the other side, Tracey Woodruff, an environmental professor at the University of California - San Francisco, argued more stringent regulations are needed to protect public health.

Drugs & Biologics

FDA took major strides for a couple of non-small cell lung cancer (NSCLC) treatments this week. Merck announced its cancer drug Keytruda (pembrolizumab) in combination with platinum-containing chemotherapy was approved for some patients with NSCLC who may have their cancer removed with surgery. The combination treatment has been approved as a neoadjuvant treatment before surgery and can be used alone as an adjuvant treatment after surgery.

The week started out well for AstraZeneca too, which announced that its cancer drug Tagrisso (osimertinib), in combination with chemotherapy, was granted priority review by FDA to treat adults with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) NSCLC. In an early trial, the company noted that the combination of Tagrisso with chemotherapy reduced disease progression or death by 38% compared to treating patients with just the drug.

AstraZeneca shares, however, fell about 4% by mid-week according to Reuters after disappointing results from another lung cancer late-stage trial where patients were treated with datopotamab deruxtecan. An analyst noted the drug only improved mortality of lung cancer patients on the drug by 0.7 months compared to patients treated with chemotherapy.

Medtech

Masimo announced that its ORi function used with its multi-wavelength Masimo rainbow Pulse CO-Oximetry platform has received de novo authorization as a first-of-its-kind product to detect hyperoxia in patients undergoing surgery. The company noted that the product is a noninvasive and continuous parameter that keeps surgeons abreast of potential hyperoxia while patients receive supplemental oxygen.

FDA has updated the list of products the agency has allowed on the market with artificial intelligence/ machine learning (AI/ML) capabilities. The list demonstrates a massive increase in such products. Since 1995, the agency has greenlit almost 700 AI/ML products, and a fifth of those products were given the nod in just the past year.

FDA and the National Institutes of Health’s (NIH) National Cancer Institute (NCI) announced a funding project for small businesses to develop medical device development tools (MDDT) that can be used to develop datasets to diagnose and treat cancers. Stakeholders can apply for the funding opportunity until 14 November.

This Week at FDA: Regulators publish guidances, announce meetings, ask for clinical trial feedback

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