FDA Roundup: August 4, 2023

FDA News Release

• For Immediate Release: August 04, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA issued a new guidance for immediate implementation, “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs),” which provides drug manufacturers and applicants with a recommended framework for a risk-based safety assessment of NDSRIs that could be present in approved and marketed drug products, as well as products under review by the FDA.
• On Thursday, the FDA authorized marketing for Viz.AI’s Viz HCM, a standalone electrocardiogram (ECG) analysis software to identify patients 18 or older for further follow-up for hypertrophic cardiomyopathy (HCM), a rare condition in which the heart muscle becomes abnormally thick and makes it difficult for the heart to pump blood. This device can analyze recordings from compatible 12-lead ECGs, detect signs associated with HCM, and allow the user to view the ECG and software analysis. The device does not provide a diagnosis of HCM and is not intended for use on patients with implanted pacemakers.
• On Thursday, the FDA’s Office of Regulatory Affairs announced that it is hosting a free hybrid public meeting entitled “Modernizing Food and Drug Administration Recalls Listening Session” on September 29, 2023. This listening session will provide an opportunity for stakeholders to share information and feedback about topics related to recall modernization for FDA-regulated products. The FDA is inviting comments from all interested stakeholders and has identified the following examples of topic categories of the type of information the agency is interested in obtaining. Registration is required. The registration deadline for speaking is September 1, 2023. For more information, please see the meeting announcement page.
• On Wednesday, the FDA approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. FDA had previously approved single-agent LONSURF for this indication in September 2015. The most common adverse reactions or laboratory abnormalities for LONSURF with bevacizumab (≥20%) are neutropenia, anemia, thrombocytopenia, fatigue, nausea, increased AST, increased ALT, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain, and decreased appetite. View full prescribing information for LONSURF.
• On Wednesday, the FDA published the FDA Voices: ”Emerging From the Pandemic: CDRH In-Person Meeting Status and Premarket Workload,” by Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality, CDRH. CDRH is happy to report they are accepting and holding in-person meetings with stakeholders and have been doing so for quite some time. Additionally, CDRH has been operating under normal review timelines for all incoming premarket submissions for almost a year and accepting all submission types for review. CDRH has received more submissions for devices of new types over the past 12 months than during any 12-month period since they began tracking this metric in 2015.
• On Tuesday, CDER published a CDER Conversation where Iilun Murphy, Director of CDER's Office of Generic Drugs (OGD), discusses how OGD is conducting and funding research to better understand how the office can best educate patients and health care providers about generic drugs. Greater education and outreach to patients about generic drug standards could help dispel misconceptions about the quality and effectiveness of generic drugs. This, in turn, will promote the use of generic drugs, leading to improved medication adherence and better patient outcomes..
• This week, the Office of Regulatory Affairs released new stories and multimedia content on ORA News and Stories on fda.gov!  Highlights include feature articles about the Winchester Engineering and Analytical Center (WEAC) and the labs public-protecting work that comes from the lab and the labs work to combat both microbial and human-created hazards in medical devices and implants so that Americans don’t get sick. There is an ORA Viewpoint article from WEAC Director Brian Baker titled Protecting Public Health through Science, Partnership--and a Unanimous Belief in the Common Good, which provides a forward thinking look at how the WEAC ensures the foods we eat are safe, and that the medical devices—used to diagnose and treat disease for millions of Americans--are safe, effective, and able to perform precisely as intended. Published quarterly, ORA News and Stories is a new webpage on FDA.gov/ORA that features the news, expert perspectives, and stories from and about ORA employees who are on the frontlines protecting public health.