This Week at FDA: CDRH annual report, partial shutdown update, 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’s device center released its annual report for 2025, touting a record number of novel devices authorized last year, and some legislation affecting FDA could be included in a government funding deal.

On Wednesday, FDA’s Center for Devices and Radiological Health (CDRH) released its annual report for 2025. According to the report, CDRH authorized 124 novel medical devices, including the first blood test developed to diagnose Alzheimer's disease last year. This figure represents “one of the highest annual totals in the Center's more than 40-year history.” The report also stated that the Center received 21,780 submissions in 2025. Additionally, it noted that more than 250 devices have been authorized using real-world evidence (RWE) to date.

While a partial government shutdown affecting other federal health agencies seems likely to hit this weekend, FDA will continue operations as usual, as it has already been funded for the full year.

According CBS News, numerous federal agencies are set to see their funding expire at midnight Friday despite a spending deal reached in the Senate. This agreement, intended to prevent a partial shutdown, must be approved by the House, which is not expected to return to Washington until Monday.

On Thursday, Democratic senators negotiated with the White House and Republican leaders to remove funding for the Department of Homeland Security (DHS) from a package of six spending bills. The plan involves passing the remaining five bills and extending funding for DHS at current levels for an additional two weeks to facilitate discussions on reforms to immigration enforcement. While FDA’s funding isn’t on the line, the spending package does include measures that would impact the agency, including the Mikaela Naylon Give Kids a Chance Act, which would enable the FDA to mandate pediatric studies for combinations of targeted cancer drugs. Additionally, it would reauthorize the Pediatric Disease Priority Review Voucher (PRV) program until 30 September 2029.

STAT reported that ImmunityBio officials were surprised that FDA rejected its cancer drug Anktiva after having given support for the drug at a January 2025 meeting. Yet FDA officials rejected these claims and asserted that at “no point during or after the January 2025 meeting with ImmunityBio did anyone at the FDA endorse the Anktiva data, nor did anyone suggest that a submission would be accepted and reviewed,” according to persons “with knowledge of the FDA’s side of this story.”

According to Bloomberg, Moderna CEO Stephane Bancel said the company does not plan to invest in new late-stage vaccine trials because of opposition to immunization from US health officials. His comments were made during the World Economic Forum in Davos, Switzerland.

The Trump Administration is asking a federal court to pause a lawsuit filed by Louisiana that seeks to impose nationwide restrictions on abortion pills, reported Politico. This request comes as FDA reviews of the safety of the drug and considers whether to restrict access. Allowing Louisiana’s lawsuit to proceed before that process is complete, the Justice Department argued, would “threaten to short circuit” sensitive regulatory and scientific work.

In agency personnel news, The Pink Sheet reports that FDA’s Sarah Ibrahim was named CDER Acting Deputy Director for Regulatory Programs and fills a position that has been vacant since Douglas Throckmorton retired a year ago.

FDA has released two reports on its conference hosting expenses in 2025. One report details expenses on FDA-held conference with expenses in excess of $100,000, and the other details scientific conferences with expenses over $30,000.

According to a report in PoliticoPro, the Trump administration is postponing the launch of its website, TrumpRx, which was announced in the fall as a platform for Americans to purchase discounted prescription medications directly from manufacturers. During a Cabinet meeting on Thursday, HHS Secretary Robert F. Kennedy Jr. stated that the launch "is going to be happening sometime, probably in the next 10 days."

FDA Commissioner Marty Makary spoke at a White House event focused on addiction on Thursday, coinciding with an executive order to launch the Great American Recovery Initiative. Makary announced that FDA will be evaluating devices and drugs aimed at treating treat addiction through its voucher program.

Drugs & Biologics

Regenxbio on Wednesday announced that FDA placed a clinical hold on its investigational gene therapy, RGX-111, for treating MPS I, also known as Hurler syndrome. This decision follows a preliminary analysis of a single case of an intraventricular CNS tumor in a five-year old boy who was treated in its Phase I/II study. Additionally, FDA placed a clinical hold on RGX-121 for treating MPS II, or Hunter Syndrome. This action is based on the similarities between the two products, their study populations, and the shared risk observed in the clinical studies.

FDA announced the approval of daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

FDA and the Center for Research on Complex Generics (CRCG) announced they will be conducting a survey to help identify topics that for a workshop in December to identify information and guidance that would be helpful to drug developers regarding BE frameworks and quality perspectives for long-acting injectables.

FDA has announced it is seeking public comment for a future public workshop series under its “Rare disease Innovation, Science, and Exploration (RISE) that focuses on challenges that are common to multiple diseases or a class of diseases. The workshop will focus on cross-cutting issues and will not be focused on any specific product under review by the Agency. The deadline for submitting comments is 31 December 2026.

FDA issued a warning letter to Fulijaya Manufacturing in Malaysia. Among the violations was a failure to maintain logbooks for raw data for microbiological release and stability testing of its OTC drug products. The company also failed to conduct growth promotion testing of its microbiological media to assure suitability and failed to conduct stability testing of its drug products.

FDA’s Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to ARS Pharmaceutical Operations located in San Diego, CA claiming that its direct-to-consumer (DTC) broadcast advertisement for NEFFY (epinephrine nasal spray) (Neffy) was “false and misleading” and is being unlawfully distributed under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Medtech

CDRH released its International Harmonization Annual Assessment for Fiscal Year 2025 which provides an update on its activities in the harmonization realm.

FDA announced it will be holding a town hall for industry to discuss its final guidance on General Wellness: Policy for Low Risk Devices, Final Guidance on 11 February.

FDA issued a warning letter to Meridian Bioscience following an August inspection of its site in North Billerica, MA for failing to open a CAPA it began noticing an increase in patient false positive complaints (PATFP) associated with its collection tubes used with its LeadCare II Blood Lead Test Kit. FDA said the company identified approximately 179 complaints from October 2024 to 14 August 2025.

FDA issued a warning letter to MAST Biosurgery USA in Irvine, CA, a manufacturer of surgical polymeric mesh devices for failing to conduct endotoxin testing for its SurgiWrap devices. FDA also said the company had inadequate complaint handling procedures. One complaint alleges that eight out of 10 patients developed abdominal swelling after undergoing procedures involving SurgiWrap.

This Week at FDA: CDRH annual report, partial shutdown update, and more

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