FDA Policy/General
While many government agencies will have to deal with significant budget cuts next year, FDA’s just-released proposed fiscal year 2027 budget seeks a 3.3% increase or about $200 million to fund the agency’s operations. As proposed, the budget would total $7.2 billion, which includes $3.
Devices
FDA’s updated guidance on incorporating patient preference information (PPI) into regulatory decision-making for medical devices and biologics signals a constructive shift for the 510(k) pathway. By explicitly acknowledging the relevance of PPI in these submissions, the agency is opening the door to a more patient-centered evidentiary
FDA Policy/General
FDA commissioner Marty Makary this week shared an expansive vision for future medical breakthroughs, telling agency staff (audio link – begins at 47:28 mark) he hopes to see transformative treatments — and potentially cures — across a range of serious diseases in the coming years Speaking about long-term priorities, Makary pointed
Drugs
FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for submitting postmarketing safety reports, according to a notice scheduled for publication in the Federal Register. The requirement applies to individual case safety reports (ICSRs) for human drugs, biologics and certain
Drugs
FDA has granted Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovarian cancer, a difficult-to-treat form of the disease with limited options. CTIM-76 is described as a T cell–engaging bispecific antibody designed to target CLDN6-positive tumors by
FDA Policy/General
HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has sparked concern among former agency officials and public health experts. HHS secretary Robert F. Kennedy Jr. has criticized FDA’s earlier action as “illegal,
Biologics
CBER has issued a Standard Operating Policy and Procedure (SOPP) for filing an application when the applicant protests a refusal-to-file (RTF) action. The SOPP applies to NMEs, NDAs, original BLA submissions, and associated efficacy or manufacturing supplements, including those subject to PDUFA, BsUFA, and non-PDUFA products. When
Devices
FDA says it is “redoubling efforts to utilize real-world evidence (RWE) across a wider range of medical devices to support timely access to safe and effective technologies, foster innovation, and strengthen the foundation of regulatory decision-making.” To that end, the agency has published a new set of 73
Drugs
In a 4/1 letter to two FDA senior officials, FDA commissioner Marty Makary says the agency does not intend to enforce two sections of the Federal Food, Drug, and Cosmetic Act involving adequate directions for use and new drug approvals with respect to an orally administered, hemp-derived CBD
Drugs
(Editor's note: Late on 4/2, the White House released a Fact Sheet about the tariffs.) President Trump is reportedly preparing to impose sweeping new tariffs on certain pharmaceutical imports, targeting companies that have not agreed to participate in his administration’s “Most Favored Nation” (MFN) drug pricing
Devices
FDA has denied a 2025 petition that asked the agency to exempt specific radiology computer-aided detection and/or diagnosis (CAD) devices and computer-aided triage and notification devices (CADt) from 510(k) requirements. The agency denial letter says the petition asked for exemption from the premarket notification requirements for
Drugs
A bipartisan pair of senators is pressing FDA to take a more proactive role in policing prescription drug advertising, citing a surge in misleading direct-to-consumer promotions — for weight-loss treatments. In a letter sent this week, Dick Durbin (D-IL), the Senate Democratic Whip, and Roger Marshall (R-
Biologics
Ultragenyx Pharmaceutical has resubmitted a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilippo syndrome Type A, a rare and fatal pediatric neurodegenerative disorder. Sanfilippo syndrome type A is described as a rare inherited lysosomal storage disorder caused by mutations in the SGSH gene,
FDA Policy/General
In a wide-ranging 4/1 address to employees at FDA, commissioner Marty Makary outlined an expansive agenda to accelerate drug approvals, lower costs, and modernize the agency — while maintaining its core commitment to safety. Makary’s address (available recording), which coincided with his one-year anniversary at FDA, emphasized
Biologics
FDA has granted full approval for Kite’s CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL), converting its prior accelerated approval into a traditional approval based on confirmatory clinical data. The decision is based on updated results from the ZUMA-
Drugs
The Rare Disease Advocacy, Biotechnology, and Investor Coalition, which has nearly 100 rare disease patient advocacy groups, biotechnology executives, and investors as members, is urging the Trump administration to use the appointment of a new CBER director to restore regulatory clarity for rare diseases. The new appointee will replace Vinay
Drugs
A 4/29-5/9/2025 FDA inspection at the LeeSar drug outsourcing facility in Fort Myers, FL, found multiple violations in the firm’s production of compounded drugs. A just-released 11/21/2025 Untitled Letter lists these violations: * failure to meet the conditions of Section 503B, such as
Devices
A 4/29-6/18/2025 FDA inspection at the Physitemp Instruments facility in Clifton, NJ, found multiple violations in the firm’s manufacturing of clinical electronic thermometers, clinical temperature monitoring probes, and a needle microprobe. A just-released 11/12/2025 Warning Letter said specific Quality System Regulation violations
Drugs
A three-judge panel of the 5th Circuit Court of Appeals heard oral arguments on 3/30 in a challenge to FDA’s finding that popular weight loss drugs are no longer in short supply and thus cannot be legally compounded except in very restricted circumstances. Courthouse News Service reports
Drugs
FDA is prioritizing efforts to accelerate drug development timelines beginning at the investigational new drug (IND) stage, while also pushing to expand over-the-counter (OTC) access and modernize regulatory processes, commissioner Marty Makary said Wednesday. Speaking during a press briefing, Makary emphasized that the agency is rethinking the full
Drugs
FDA has extended by three months its review of an Orca Bio BLA for its experimental cell therapy Orca-T, pushing the agency’s decision deadline to 7/6. The submission is seeking approval for the therapy to treat a range of hematologic malignancies, including acute leukemias and myelodysplastic syndromes.
Biologics
Xbrane Biopharma said it expects to resubmit a BLA before June for ranibizumab, a biosimilar copy of Genentech’s Lucentis, which is indicated for treating neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Ranibizumab is an anti-vascular endothelial growth factor therapy that