This Week at FDA: Overton nomination hearing, FDA’s hiring challenges, 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, a Senate committee scheduled a hearing for President Trump’s nominee to lead FDA, new reporting sheds light on the agency’s hiring challenges, and the agency held two meetings to consider the use of psychedelic drugs for mental health disorders and the use of testosterone in menopausal women.
The Senate Health, Education, Labor, and Pensions (HELP) Committee has scheduled a hearing to review the nomination of Heidi Overton, who Trump has nominated to succeed Marty Makary as Commissioner of Food and Drugs following Makary’s resignation from the post in May. Trump nominated Overton, a White House policy aide and preventive medicine physician, for the position in August. Reuters reports that Overton previously worked for the America First Policy Institute and spoke at an event in August in which Trump signed an executive order to overhaul the childhood vaccine schedule.
According to a report in Politico Prescription Pulse, Overton is gaining support among Republican politicians, after meeting with senators this week, including Sen. Roger Marshall (KS), who posted that “she understands the hope patients and families have for new treatments, from cancer and rare diseases to the next breakthrough for Alzheimer’s. She’ll help safely get life-saving drugs to patients faster and I look forward to supporting her nomination,” alongside photo with Overton on X. Sens. Ashley Moody (FL) and Josh Hawley (MS) have also signaled their support for Overton.
FDA’s rebuilding effort are facing challenges as the agency’s HR staff grapples with hiring after DOGE cuts and resignations resulted in thousands of departures from the agency, according to a STAT News report. These hiring goals are hindered by bureaucratic delays. Three current employees, who spoke on the condition of anonymity, told STAT that DOGE’s attempts to centralize individual human resources offices have failed and are “creating bottlenecks and confusion.” An agency spokesperson told STAT via email that FDA has hired 1,050 staff since October 2025 and is in “the final stages of the hiring process preparing to onboard in the next few months.”
MedPage News reports that most of the 80 speakers at a hearing on Monday expressed “strong support” for the therapeutic use of psychedelic medicines. They highlighted the potential for psychedelic drugs to treat severe mental health conditions, such as major depressive disorder and post-traumatic stress disorder (PTSD). However, several participants raised concerns about the need for standardization in clinical trials, the need for risk evaluation and mitigation strategies (REMS), and patient safety.
Reuters reports that FDA has requested additional data on testosterone therapies for women. FDA officials have encouraged manufacturers to conduct studies that could support future approvals of female-specific products. While companies may be able to use data from testosterone products that have been approved in other countries, they must still meet US regulatory standards. Currently, there are no FDA-approved testosterone therapies for women.
Drugs and Biologics
On Friday, FDA announced that it will begin accepting applications for its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) starting on 1 October. Now in its fifth year, this program aims to accelerate the CMC development of products under an investigational new drug application (IND) to provide earlier patient access to these products. The announcement also details the eligibility criteria and the process for submitting a request to participate in the pilot.
FDA has released a draft strategy document titled “BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document.” This document summarizes the discussions from the FDA public workshop, “Advancing the Development of Interchangeable Products: Identifying Future Needs,” held on 19 September 2025. It also outlines FDA’s future plans to support the development of interchangeable biosimilar products. The public has 60 days to provide comments on the document.
FDA’s Center for Drug Evaluation and Research published a study titled “First-Cycle Complete Response Rates for CDER NDA and BLA Applications.” The study aims to challenge the belief that first-cycle complete response (CR) rates have risen over time. It found that the first-cycle CR rates decreased from 47% in fiscal year (FY) 2008 to approximately 27% in FY 2024. Additionally, over the 16-year study period (FY2008–FY2024), the mean first-cycle CR rate was 33.7%.
Three FDA guidance documents have reached the Office of Management and Budget (OMB) and are currently under review prior to publication, including Improving Patient Access to Deceased Donor Islet Cells and Cell Products, Regulatory Considerations for Prescription Drug Use-Related Software, and Potency Assurance for Cellular and Gene Therapy Products.
FDA said it has approved Ultragenyx Pharmaceuticals’ Fayuvi (rebisufligene etisparvovec-hopf) as the first treatment specifically designed for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A. MPS IIIA is a rare inherited disorder that progressively causes damage to the brain and nervous system, leading to a decline in cognitive, language, and other developmental abilities over time.
Bayer announced that its drug, Kerendia (finrenone), has been approved as the first new treatment option in over 30 years for adults with chronic kidney disease (CKD) related to type 1 diabetes (T1D). This development addresses a significant unmet need for a population at a higher risk of kidney failure, as approximately 30% of individuals with type 1 diabetes in the US develop CKD.
FDA has approved the first generic radioligand equivalent of Novartis' cancer drug Lutathera, as reported by Fierce Pharma. Curium's lutetium Lu 177 dotatate injection, branded as Bexlutry, is designed to target the somatostatin receptor and deliver a radioactive payload. It is indicated for specific gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
FDA issued a safety communication announcing that a warning has been added to the labeling for Kybella (deoxycholic acid) injection. This warning addresses potential adverse reactions that may occur if the drug is used outside of the submental fat region or for purposes other than treating fat underneath the chin.
The agency published a new draft guidance addressing the development of blood collection, processing, and storage systems intended for the manufacture of blood and blood components for transfusion using the buffy coat (BC) method and on regulatory submissions to Food and Drug Administration (FDA) for such products.
FDA has scheduled a public workshop on 23 September to discuss next-generation sequencing (NGS) for adventitious agent (AA) detection in biologics. The workshop will focus on assessing the readiness of NGS technologies for detecting these agents, identifying existing challenges, and exploring potential solutions to encourage the adoption of NGS-based methods for AA detection in biological products.
The agency also announced a workshop on drug registration and listing workshop for 29 September. The workshop will provide the latest updates on submitting accurate registration and listing data to help avoid submission errors. It will also cover drug amount reporting requirements and compliance outcomes. Additionally, the workshop will explain the final rule Revising the National Drug Code Format and drug label barcode requirements, as well as the future format of the NDC.
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBAC) is set to meet on 1 October 2026, to discuss strain selection for influenza virus vaccines for the 2027 Southern Hemisphere influenza season.
Medical Devices
FDA has released draft guidance to help applicants who want to submit Premarket Approval applications (PMAs) and certain PMA supplements to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The guidance outlines the current publicly available resources that support these submissions to FDA.
The agency has announced that Medtronic and its subsidiary Given Imaging, Inc., have notified customers to remove certain esophageal pH monitoring capsule delivery devices from use or sale. The affected devices include the Bravo CF capsule five-pack and the single pack delivery devices.
FDA has scheduled an upcoming public advisory committee meeting of its Microbiology Devices Panel on 19 November to discuss the scientific, clinical, and public health dimensions of the use of pathogen-agnostic sequencing in relation to emergency preparedness and response efforts.
FDA has denied a partial exemption from the premarket notification requirements for radiological computer-assisted diagnostic software related to lesions suspicious of cancer; medical image analyzers; radiological computer aided triage and notification software; and radiological computer-assisted detection and diagnosis software.
