This Week at FDA: FDA seeks input on CNPV, new approvals, 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 said it wants to gather public feedback on the Commissioner’s National Priority Voucher program, amid questions about the validity of claims about its speed by FDA Commissioner Marty Makaray.FDA announced on Friday that it is giving members of the public a chance to comment on its latest priority voucher program. The agency also announced a public hearing on 12 June to solicit stakeholders’ comments. The program was established in June 2025 to provide an expedited review process for drugs and biological products deemed to have "strategic national importance."
Agency IQ on Wednesday reiterated concerns about Makary’s claims that two recent approvals under the CNPV program were unprecedented in their speed. Makary has been calling these approvals record-breaking, including during a recent Center for Medicare & Medicaid Services conference and in a Fox Business interview.
Specifically, Agency IQ took issue with Makary’s claims that the agency approved Janssen’s Tec-Dara (teclistamab) in 55 days and Boehringer Ingelheim’s Hernexeos (zongertinib) in 44 days. While these approvals were rapid, they were not unprecedented in terms of speed, Agency IQ wrote, because the FDA was not comparing equivalent review processes. Specifically, the days counted by Makary only included the time from when the product was accepted for review by the FDA, excluding the period between the application submission and acceptance, which typically takes about two months. When including time from submission to approval, the total review period for Tec-Dara was 90 days, while the review for Hernexeos spanned 104 days.
One of the latest approvals made under the program was for Novo Nordisks’s Wegovy (semaglutide) injection. On Thursday, FDA announced the approval of a new higher dose (7.2 mg) of the drug. The medication is intended for weight loss and the long-term maintenance of weight loss in certain adult patients. The decision was made 54 days after the application was submitted, marking the fourth approval under the CNPV pilot program.
On Monday, a federal judge paused the Trump administration’s overhaul of the childhood vaccine schedule in a court order that deals a setback to HHS Secretary Robert Kennedy Jr., according to a report in STAT News. Richard Hughes, the chief litigator that challenged the overhaul, wrote an opinion piece in MedPage Today on the implications of the decision. Hughes is lead counsel for the American Academy of Pediatrics.
FDA published over-the-counter monograph drug facility fee rates for fiscal year 2026. The new fees are set to decrease by 50% compared to the previous year and are due on 1 June 2026.
STAT News also reported that NIH grant awards are lagging far behind historical averages; nearly halfway into the fiscal year, the agency has spent 74% fewer new awards than the average for the same period in the 2021-2024 fiscal years, according to an analysis of NIH RePORTER data by researchers at Johns Hopkins.
This week, US Senators Pete Ricketts (R-NE) and Richard Blumenthal (D-CT) wrote a letter to Makary urging scheduling action of the whole Kratom leaf and 7-OH under the Controlled Substance Act (CSA) based on their concerns about this drug’s addictive qualities and to restrict its use.
Drugs & Biologics
FDA approved GSK’s Lynavoy (seladelpar), an ileal bile acid transporter (IBAT), which is the first medicine approved in the US for the treatment of cholestatic pruritus stemming from primary biliary cholangitis (PBC), according to a report in MedPage Today. PBC is a rare but serious autoimmune disease that disrupts bile flow from the liver.
FDA released final guidance on “Pyrogen and Endotoxins Testing.” This guidance outlines recommendations for firms involved in biological product, drug, and device firms regarding FDA’s current perspective on testing recommendations and acceptance criteria.
FDA issued a warning this week about the risk of Vitamin B6 deficiency and its connection to seizures in patients using drug products containing carbidopa/levodopa. The warning advises health care professionals to assess baseline vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies and to monitor these levels while patients are being treated.
FDA announced a meeting on expanded access to investigational drugs for treatment use on April 15. Expanded access allows patients with serious or immediately life-threatening diseases to access investigational drugs outside of clinical trials when no suitable alternative treatment options are available.
FDA's Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Therapeutic Products (OTP) and the Alliance for Regenerative Medicine (ARM), is hosting a hybrid workshop scheduled for 9 April on "Advancing Pediatric Cell and Gene Therapy Clinical Trials." The meeting will focus on the challenges and considerations involved in conducting clinical trials for cell and gene therapies (CGTs) in pediatric populations.
CBER also released new Standard Operating Procedures (SOPs) for processing requests for Regenerative Medicine Advanced Therapy (RMAT) designation. The updated guidance clarifies that if an Investigational New Drug (IND) application is placed on clinical hold, it does not automatically render the product ineligible for RMAT designation.
In personnel news, Adam Sherway, the director of the Office of Infectious Diseases in FDA’s drug center told colleagues on Wednesday that he will be leaving the agency effective 4 April, reports STAT.
Medtech
The FDA’s Center for Devices and Radiological Health (CDRH) released a report to Congress earlier this week stating that from January 2023 to December 2024, the agency issued 51 device-related safety communications.
FDA has approved Trilogy Transcatheter Heart Valve System for treating symptomatic severe aortic regurgitation, device maker JenaValve announced. The company said the approval represents the first transcatheter device in the US with this indication.
FDA posted a warning letter to Avertix Medical in Eatontown, NJ earlier this week citing the firm for quality system regulation and medical device reporting violations related to its Guardian System.
The New York Times reports that Boston Scientific was aware of issues with its pacemaker batteries that caused them to fail unexpectedly.
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