This Week at FDA: No Overton vote until after midterms, FDA signals advisory committee support, 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, we learned that the White House’s nominee to lead FDA won’t get a confirmation vote until after the US November mid-term elections, that FDA seems to be restrengthening its advisory committee system, and more.

After last week's Senate Health, Education, Labor, and Pensions (HELP) committee hearing to consider White House advisor Heidi Overton as the new FDA commissioner, STAT News reported that she won't be up for a vote in the Senate until after 9 November, when the Senate reconvenes. The outlet noted that it would take only one Republican vote to sink her nomination in the HELP committee.

In what one expert called a signal that FDA is making a significant course change, the agency this week issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the role of FDA's advisory committees was greatly diminished under former Commissioner Marty Makary.

FDA also announced it is renewing its Antimicrobial Drugs Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee until 7 October 2028.

FDA issued a statement this week that the Department of Justice has charged two Indian nationals with conspiracy and smuggling related to an alleged transnational counterfeit prescription drug distribution scheme. The agency said the accused allegedly obtained counterfeit versions of Ozempic (semaglutide) from unauthorized sources in China and sold the drugs in the US at deeply discounted prices.

The International Council for Harmonisation's (ICH) E2B(R3) data standards have been adopted by FDA. The standard is used to electronically transmit Individual Case Safety Reports (ICSR) when sharing adverse event information.

FDA updated the public on new safety information or potential safety signals found in its Adverse Event Monitoring System (AEMS), formerly known as the FDA Adverse Event Reporting System (FAERS), based on data analyzed between April and June 2026. The agency listed 21 drug, biologic, generic, and biosimilar products that it is evaluating for potential regulatory action.

Lowell Zeta, acting chief of staff and deputy FDA commissioner for strategic initiatives and special counsel, published a blog post outlining the agency's transparency roadmap that includes publishing complete response letters and signing a memorandum of understanding with the Securities and Exchange Commission to establish a framework for sharing nonpublic information about regulated products. He said the agency is also working to provide more transparency on new approach methodologies (NAM); novel biomarkers; compliance, especially regarding direct-to-consumer (DTC) advertising; inspectional records; and to finalize a rule on a new type of medication guide to make labeling more consumer-friendly.

As part of FDA's efforts to reorganize and centralize its offices and operations in July, the agency published a new website stating that its Division of Industry and Consumer Education (DICE) is now the Office of Industry and Consumer Education (OICE). The website has new contact information for stakeholders.

FDA announced it has updated its Form 356h: application to market a new or abbreviated new drug or biologic, and Form 1571: application to market an investigational new drug. The agency said the changes are intended to ensure it is collecting data required for the Prescription Drug User Fee Amendments (PDUFA), Biosimilar User Fee Amendments (BsUFA), and Generic Drug User Fee Amendments (GDUFA) programs.

Former Rep. Eric Cantor (R-VA) will take over as the next president and CEO of PhRMA, the largest drug lobby group in the US, on 9 November, after its current CEO Steve Ubl steps down. A former Republican House majority leader, Cantor left Congress in 2014 after losing a primary election and served as vice chair and managing director at the global investment bank, Moelis and Company.

Drugs & Biologics

FDA will host a webinar on 29 October to discuss its final guidance issued in June that adopted the ICH M15 guideline on general principles for model-informed drug development. The webinar will include a prerecorded presentation on the ICH guideline and a live session to engage stakeholders.

The Center for Biologics Evaluation and Research (CBER) reviewed a standard operating policy and procedure (SOPP) guideline on the assignment of core proper names for biological drug products and the addition of a suffix to certain original and biosimilar products. The agency said its review found the guideline was current on its quality management system (QMS) requirements.

CBER also updated an SOPP guideline on its procedures for conducting parallel scientific advice with the European Medicines Agency (EMA). The biologics center said it made technical updates to the document and similarly reviewed the guideline to ensure it was current with its QMS requirements.

Egetis Therapeutics’ drug Emcitate (tiratricol) was approved by FDA as the first treatment for peripheral thyrotoxicosis in patients with MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome. The rare genetic disorder mainly affects men and causes excess thyroid hormone levels in the blood that may lead to rapid heart rates, increased blood pressure, and adverse effects on their metabolism.

FDA approved Bristol Myers Squibb's heart drug Camzyos (mavacamten) as the first treatment for symptomatic obstructive hypertrophic cardiomyopathy (oHCM), an inherited disease, in children weighing at least 30 kg. Approved for adults since 2022, the drug is available only through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) program.

Medtech

Booz Allen published its latest independent evaluation of whether the Center for Devices and Radiological Health (CDRH) has met its commitments under the Medical Device User Fee Amendments (MDUFA V) deal with the medtech industry, noting that so far, the agency has kept up its end of the deal. While several metrics are still under evaluation, the agency is expected to meet those commitments as well.

Solutions used for flushing and storing vascular autografts at room temperature were classified by FDA as class II devices with special controls. Manufacturers of the solutions are asked to implement mitigation measures, including conducting biocompatibility evaluations, clinical and non-clinical performance testing, shelf-life testing, sterilization validation, and compliance with labeling requirements.

A subsidiary of Edwards Lifesciences, Autus Valve Technologies' Autus Size-Adjustable Valve has been approved by FDA as the first heart valve designed to be expanded after surgery to keep pace with growing children, and the first valve approved in the US to use polymeric material rather than animal-derived tissue for its inner flaps. The pulmonary heart valve is intended to be surgically implanted in children with congenital pulmonary valve disease and is supposed to reduce the need for repeat open-heart surgeries.

CDRH has updated its webpage detailing the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge, adding new participants and devices. Since September, the agency has added Becton, Dickinson and Company; Current Health Limited; and Skribe Medical, which are developing home self-collection blood sampling kits, artificial intelligence (AI) software to detect patients at higher risk for cytokine release syndrome (CRS), and a wearable to estimate left ventricular ejection fraction (LVEF).