This Week at FDA: Single pivotal trials, FDA reverses course to review Moderna flu vaccine, and Makary’s OTC turn

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, top FDA officials announced that the agency would require only a single pivotal trial for most drugs, the agency reversed course and said it would review Moderna’s mRNA influenza vaccine, and FDA Commissioner Marty Makary said that most drugs should be available over-the-counter (OTC).

The big news this week is that FDA Commissioner Marty Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), announced in the New England Journal of Medicine (NEJM) that the agency will, by default, require only a single pivotal clinical trial for most drugs. In the article, they laid out their rationale for changing the decades-old standard requiring at least two confirmatory trials for drugs and biologics, arguing that the previous standard was based on the limited understanding of biology of the time and that there are alternative ways to ensure products meet safety and efficacy requirements.

A week after Prasad reportedly overruled CBER staff and issued a refuse-to-file (RTF) letter to Moderna for its mRNA influenza vaccine, the company announced the agency had reversed course and would now evaluate its biologics license application (BLA). The company said it met with the agency during a Type-A meeting and proposed a revised regulatory approach that would evaluate the vaccine for full approval in adults 50 to 64 years of age and accelerated approval in adults 65 and older, with a post-marketing plan to conduct an additional study in older adults, which was accepted.

Following the news, Politico reported that FDA reversed its decision on Moderna's vaccine after President Donald Trump voiced frustration to Makary in a meeting two days after news broke about the RTF letter over the agency's handling of vaccine issues, according to sources. A White House official, however, denied that the president had raised the issue of FDA’s vaccine policy in general or the Moderna vaccine more specifically.

FDA has recently been gathering feedback from industry and other stakeholders on how to increase access to over-the-counter (OTC) nonprescription drugs as part of the Trump administration's efforts to lower drug prices. This week, Makary discussed the matter on CNBC, where he said regulators must get away from their "paternalistic mindset" and trust people to be able to take medications without physician involvement.

"In my opinion, everything should be over the counter, not requiring a prescription, unless it's unsafe, unless you need a laboratory test to monitor how it's being received by your body, or if it could be used for some nefarious purpose, or it's addictive," said the Commissioner. "If it doesn't meet those criteria, why should a drug be over the counter?"

Jay Bhattacharya, director of the National Institutes of Health (NIH), was named as the new acting director of the Centers for Disease Control and Prevention (CDC) after Jim O'Neill was dismissed last week, making him the fifth director to be dismissed in the past year. Politico reported that Kyle Diamantas and Grace Graham were also named senior counselors at FDA in the shakeup.

The Duke-Margolis Institute for Health Policy and FDA Rare Disease Innovation Hub are scheduled to co-host a meeting on 30 March to discuss sharing data on rare disease treatments to help with the product development and regulatory review process. The organizers said it will also be an opportunity to discuss topics such as data sharing practices, impact of data sharing during regulatory submissions, and logistical and legal challenges during data sharing.

FDA has withdrawn, corrected, or added a slew of international consensus standards that it recognizes for medical devices. The modified list of standards covers a wide array of topics and devices, including anesthesiology devices, device biocompatibility, and the materials used to make devices.

Drugs & Biologics

CDER is hosting the two-day hybrid 2026 Generic Drugs Forum (GDF) starting on 22 April, which aims to bring together generic drug industry representatives, regulatory professionals, and other stakeholders. The agency said it will be an opportunity to discuss topics such as controlled correspondence, pre-abbreviated new drug application (pre-ANDA) submissions and meetings, and quality and manufacturing issues.

AstraZeneca's cancer drug Calquence (acalabrutinib) in combination with AbbVie and Genentech's Venclexta (venetoclax) was approved by FDA to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The agency noted that acalabrutinib's prescribing information includes warnings and precautions for serious and opportunistic infections, hemorrhage, cytopenias, second primary malignancies, cardiac arrythmias, and hepatotoxicity.

Medtech

The Center for Devices and Radiological Health (CDRH) is scheduled to host a town hall on 11 March to discuss the agency's recently updated and finalized guidance on clinical decision Support (CDS) software. The updated guidance is intended to address industry concerns from the previous version that the agency had overstepped its regulatory authority in regulating CDS software.

FDA published December 2025 data trend for its Global Unique Device Identification Database (GUDID) system, which registers unique device identifiers (UDI) from medical devices. While the number of new companies added to the system started to increase last year, December saw a significant drop.

FDA issued an early alert to consumers about Trividia Health's True Metrix blood glucose monitoring system after learning that an error in the owner's manual could lead users to delay seeking treatment. More specifically, the explanation for the E-5 error code could lead users to think that it is a test strip error rather than a high glucose event.

This Week at FDA: Single pivotal trials, FDA reverses course to review Moderna flu vaccine, and Makary’s OTC turn

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