This Week at FDA: FDA names acting CBER director, House committee advances FDA budget bill, 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, FDA announced the appointment of Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research (CBER) and the House Appropriations committee advanced a bill to fund FDA in FY 2027.
The news was announced by PoliticoPro on Thursday. Szarama has served as Vinay Prasad’s deputy since December 2025, according to her LinkedIn profile. Before joining FDA, Szarama worked as a social science research analyst and presidential management fellow at the Centers for Medicare and Medicaid Services, director of clinical trials at Arnold Ventures, and as a program manager at the Advanced Research Projects Agency for Health (ARPA-H).
It is not clear when a permanent director will be named. During a news conference on Thursday, FDA Commissioner Marty Makary noted that the selection process is progressing but did not provide details on a timeline for a permanent director to be appointed.
Prasad left the agency at the end of April. His tenure was marked by several controversies, including overruling his reviewers to deny or delay several products, including Moderna's mRNA influenza vaccine and UniQure’s Huntington's disease treatment, as well as allegations of abusive treatment toward subordinates. (RELATED: This Week at FDA; Prasad’s second exit from FDA, ACIP backs off COVID-19 vaccine, more, Regulatory Focus 13 March 2026)
On Wednesday, the House Appropriations Committee approved legislation that would fund the FDA for FY 2027, according to an announcement from the committee. The bill would provide the agency with $7.1 billion, less than the $7.2 billion requested by the Trump administration. Rep. Rosa DeLauro (D-CT) ranking committee member, opposed the bill, asserting that the administration “is less focused on proven treatments and more attentive to Secretary Kennedy’s personal opinions,” according to an statement from her office.
In other significant news this week, Makary announced plans for a future pilot program aimed at facilitating the real-time review of clinical trials by regulators. The agency also announced the launch two proof-of-concept studies that will gather and report endpoints and other signals from early phase studies to regulators in real time. (RELATED: FDA announces efforts to advance real-time clinical trials, Regulatory Focus 29 April 2026)
Drugs and Biologics
On Monday, FDA’s Center for Drug Evaluation and Research (CDER) proposed the withdrawal of Amgen’s Tavneos (avacopan) from the market. This decision came after new information indicated that the drug has not been proven effective for its approved use. Additionally, it was found that the application leading to the FDA approval contained inaccuracies. Tavneos was approved on 7 October 2021 and is intended to be used in conjunction with glucocorticoids and other standard treatments for adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.
FDA announced on Friday that it has approved Veppanu (vepdegestrant), a breast cancer drug developed by Pfizer and Arvinas. The agency also approved the Guardant360 CDx as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with vepdegestrant.
The agency announced on Friday an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets. These tablets are now approved for treating agitation associated with dementia due to Alzheimer’s disease in adults. This approval makes Auvelity the first FDA-approved treatment for this condition that is not classified as an antipsychotic. Originally, the FDA approved Auvelity in 2022 for the treatment of major depressive disorder in adults.
On Friday, the FDA announced that it issued a “safe to proceed” letter to Revolution Medicines. This letter permits the company to start an expanded access treatment protocol (EAP) for its experimental drug, daraxonrasib, which is being developed to treat pancreatic cancer. The EAP is aimed at patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
On Thursday, FDA proposed removing three active ingredients found in GLP-1 weight loss medications—semaglutide, tirzepatide, and liraglutide—from its list of bulk drug substances. This change would limit outsourcing facilities, classified as 503B entities, from creating large quantities of compounded versions of these drugs. During an interview with Politico, Makary defended the decision, stating, “Companies that go through the front door and follow the proper process are being undermined by those that do not follow these regulations, compromising safety and efficacy.”
FDA’s Office of Prescription Drug Promotion (OPDP) is continuing its enforcement push as evidenced by two new untitled letters sent to drug makers this month. One was sent to Bayer Healthcare Pharmaceuticals for omitting important risk information for Nubeqa (darolutamine) tablets for oral use. The other went to Alnylam Pharmaceuticals for Amvuttra (vutrisan) injection for subcutaneous use. The letter claims the company “created a misleading impression that treatment with Amvuttra has shown a definitive and quantified benefit, with specific established levels of efficacy, on mortality over 3½ years, when this is not the case.”
Three FDA guidance documents are currently pending review by the Office of Management and Budget (OMB) and should be out shortly. These include: a revised draft guidance entitled Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products, and two final guidances, Statistical Approaches to Establishing Bioequivalence and Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application.
FDA’s Vaccines and Related Biological Products Advisory Committee announced an open session meeting to discuss and make recommendations on the selection of the COVID-19 formula for use in the 2026-2027 in the US.
Medical Devices
The agency on Friday announced its plan to exempt certain class II clinical toxicology test system devices from premarket notification requirements. These devices include test systems that detect a variety of substances, such as amphetamines, barbiturates, benzodiazepines, cocaine and cocaine metabolites, codeine, lysergic acid diethylamide (LSD), methamphetamines, methadone, methaqualone, morphine, opiates, propoxyphene, cannabinoids, and tricyclic antidepressants.
Medtronic has received FDA approval for its next-generation mitral valve, the Mosaic Neo, which has now been launched in the US, according to a report from MedTech Dive. This bioprosthetic valve designed to be implanted either through sternotomy, which involves separating the breastbone to access the heart, or through minimally invasive surgery.
FDA has announced that Insulet is recalling certain lots of Omnipod 5 Pods insulin pumps. Some Pods may have a small tear in the internal tubing that delivers insulin. If this happens, insulin could leak inside the Pod instead of being fully infused into the body as intended, which may lead to an under-delivery of insulin.
FDA also announced that Trividia Health is recalling its TRUE METRIX Blood Glucose Monitoring Systems due to an issue related to the E-5 error code. The recall affects the instructions provided to users in the Messages section of the owner’s booklets, as well the online labeling and help guides.
