This week at the FDA: New CDER director, end of the shutdown, 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, the longest government shutdown in history ended Wednesday evening when President Donald Trump signed a stopgap spending bill that was narrowly approved by the House earlier that day, enabling FDA to resume some work it paused during the shutdown and begin accepting submissions that require a fee.

In other major news this week, Richard Pazdur, a longtime director at FDA’s Oncology Center of Excellence (OCE), has been named the new director of FDA’s Center for Drug Evaluation and Research (CDER), replacing George Tidmarsh, who resigned amid an internal investigation involving a social media post targeting a product made by a company chaired by a former business associate.

According to Politico’s Prescription Pulse, FDA Commissioner Marty Makary paid a three-hour visit to Richard Pazdur’s home over the weekend to persuade him to accept the job, according to an anonymous source familiar with the visit. During the visit, Makary reportedly assured Pazdur he would be given autonomy and the ability to rehire people, according to the source and a second person familiar with the discussion who was granted anonymity to discuss the commitment.

The legislation to reopen the government until 30 January includes various provisions specific to the FDA, along with a full-year appropriations package for the agency. The bill allocates $6.957 billion in FY 2026 to FDA, which includes $3.422 billion in discretionary funding, as reported by Quality Assurance & Food Safety Magazine. This funding amount rejects Trump’s budget request, which aimed to cut over $400 million from the agency’s discretionary funding for FY 2026. Of this funding, $1.17 billion is specifically designated for FDA’s foods program and related field activities such as inspections, investigations and import operations, according to the text of the bill. The remaining funds are generated from user fees charged to drug and medical device companies, according to Politico Pro.

According to Agency IQ, M. Khair Elzarrad, director of CDER’s Office of Medical Policy, is set resign effective 29 November for a position outside the agency. Elzarrad’s resignation occurred before Tidmarsh’s dismissal from the agency and is not related to the event, AgencyIQ wrote. Dianne Paraoan, a 22-year veteran of the FDA and the current associate director for regulatory affairs at OMP, is expected to become acting director of OMP.

STAT News reports that two top FDA officials are “quietly upending vaccine regulations”. At a closed-door meeting of FDA vaccine scientists in September, Tracy Beth Høeg, a lieutenant to FDA Commissioner Marty Makary said she wanted to change the label of all Covid-19 vaccines to say the risks outweighed the benefits for men ages 12 to 24. CBER director Vinay Prasad stated that the decision was unnecessary since he had already restricted access to the vaccines, causing Høeg to retract her statement.

The article also reported that four agency sources from the agency informed STAT that Karin Bok, the deputy director in the Office of Vaccines, resigned last Friday.

According to the New York Times, Department of Health and Human Services (HHS) Secretary Robert Kennedy Jr, is walking a “tightrope” in light of President’s Trump’s price cutting deal announced on Thursday for obesity drugs. At the press conference that unveiled the deal, an aide to Kennedy stated that the deal was “going to have dramatic effects on human health in this country.” This represents a stark contrast to Kennedy’s previous criticisms of weight loss medications and pharmaceutical companies.

Drugs & biologics

FDA announced on Thursday its approval of Shanghai Henlius Biologic’s Poherdy (pertuzumab-dpzb) injection as the first interchangeable biosimilar to Perjeta (pertuzumab) for the treatment of certain types of breast cancer. Poherdy can be used in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

The agency also announced other approvals, including Kura Oncology’s Komzifti (ziftomenib), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no alternative treatment options. Additionally, FDA approved Janssen’s Biotech’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with high-risk smoldering multiple myeloma (SMM).

On Friday, FDA released final guidance regarding considerations for waiver requests concerning pH adjusters in generic drug drugs. This guidance is designed to help abbreviated new drug application (ANDA) applicants who are referencing a drug product intended for parenteral, ophthalmic, or otic use. It assists these applicants in seeking approval for a drug that is qualitatively (Q1) different or quantitatively (Q2) different from the reference listed drug (RLD) regarding the pH adjuster.

FDA’s Office of Generic Drugs released the minutes from its GDUFA IV Reauthorization Kickoff Public Meeting held on 11 July 2025 to kick off the process for reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 through 2032.

FDA announced on Thursday that it has qualified glutamate dehydrogenase (GLDH) as a new safety biomarker to detect drug-induced liver injury (DILI) in conjunction with alanine aminotransferase (ALT) in clinical trials. The agency said that patients with Duchenne muscular dystrophy can have elevated ALT due to muscle degeneration, which can confound a DILI signal.

On Thursday, FDA published a MAPP outlining how assessors in the Office of Generic Drugs (OGD) can apply the “Four-Part Harmony” principles to improve the clarity of communications sent to applicants during the assessment process. These communications include complete response letters, discipline review letters, and information requests.

FDA Commissioner Marty Makary announced on FDA’s direct YouTube channel that they have completed the first round of reviews of the Commissioner’s National Priority Voucher (CNPV) program, and said the program is progressing well. He stated that “[This review] shows the feasibility of the program, you know this is kind of a minimal viable product for our initial run.”

Medtech

Stereotaxis has received FDA 510(k) clearance for the latest version of its robotic magnetic navigation system designed for endovascular surgery, as reported by MedTech Dive. The GenesisX system is specifically used in ablation procedures to treat cardiac arrhythmias. It features built-in magnetic shielding, which eliminates the need for installation in the walls of operating rooms.

Tandem Diabetes Care is preparing for growth with the launch of its Mobi Tubeless pump, following FDA clearance for its Android-compatible Mobi app, while also managing numerous recalls, according to Medtech Insight.

This week at the FDA: New CDER director, end of the shutdown, and more

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