Devices
An FDA advisory committee has voted unanimously against recommending approval of Johnson & Johnson’s V-Wave heart shunt for patients with advanced heart failure who have not responded to medication, citing insufficient evidence that the implant works. The FDA’s circulatory system devices advisory panel voted 15-0 that
Devices
FDA has published a guidance, eCopy Program for Medical Device Submissions, describing how the agency is implementing the eCopy program under the FDA Reauthorization Act of 2017. The document says the eSTAR program is the current program for submissions solely in electronic format. But until eSTAR is implemented for each
Devices
FDA and the Center for Medicare and Medicaid Services’ Center for Medicare and Medicaid Innovation (CMMI) are launching the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices pilot. An FDA Digital Health Center of Excellence announcement says FDA will work with CMMI’s Advancing Chronic Care with Effective
Drugs
FDA told an 11/6 Industry Steering Committee meeting as part of the discussions toward the 2027 reauthorization of the Prescription Drug User Fee Act that it intends to present a proposal to charge different user fees depending on whether a company conducts Phase 1 trials in the U.S.
Drugs
The Sedgwick Recall Index for the third quarter of 2025 shows that while the total 97 drug recalls was the same as in the second quarter, the number of recalled units increased 137% to 44.56 million. The report says the average recall size more than doubled between the second
Biologics
CBER director Vinay Prasad addressed a 12/4 closed-door investor conference in New York and defended his leadership and attributed criticism to "misleading media narratives," according to a report by STAT News. His appearance comes the day after 12 former FDA commissioners issued an extraordinary public warning,
Drugs
CDER Office of Compliance director Jill Furman outlined a year of sweeping operational shifts, heightened enforcement, and emerging use of artificial intelligence during remarks at the Food and Drug Law Institute’s annual enforcement conference in Washington, DC, 12/4. She described the Center’s compliance program navigating two simultaneous
FDA Policy/General
FDA commissioner Marty Makary has alleged that the Biden administration failed to disclose internal data on myocarditis risks in young people following Covid-19 vaccination — a charge that federal health officials and former FDA leaders swiftly rejected as unfounded. In an interview with NBC News, Makary said an agency review
Drugs
The CDER Center for Clinical Trial Innovation says its Bayesian Statistical Analysis demonstration project provides a structured opportunity to use Bayesian approaches for the pre-specified primary analysis, supplementary analysis, or monitoring of simple trials, such as trials with a non-adaptive or straightforward sequential design. A Center online post
Biologics
CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters (CRLs) is manufacturing facility readiness, and companies are routinely misjudging when their facilities are actually prepared for an FDA inspection. In remarks delivered to the Food and Drug Law Institute’s annual
Drugs
FDA has lifted a partial clinical hold on one of Vanda Pharmaceuticals’ key tradipitant studies, clearing the company to expand dosing in an ongoing motion-sickness trial. The hold on protocol VP-VLY-686-3403 had previously capped dosing at 90 administrations of tradipitant. The FDA lifted that limitation after
Devices
FDA has issued a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop, warning that improper use could lead to serious injury or death. The alert directs clinicians to follow newly reinforced instructions and supplemental safety guidance. Olympus notified customers of the
FDA Policy/General
Writing in an online LinkedIn column, BoldApprovals managing director Steven Cohen makes the case that FDA advisory committees matter. “They make a real difference during the approval of a new treatment that has an impact at multiple levels, including public health, public policy, engagement, participation, trust, openness to the media,
Drugs
The CDER Office of Prescription Drug Promotion says a direct-to-consumer video for Daiichi Sankyo’s Turalio (pexidartinib) capsules, for oral use, is false or misleading and thus misbrands the drug. An 11/24 Notice of Violation describes the testimonial of a female patient with tenosynovial giant cell tumor
Drugs
A former senior FDA official says the abrupt resignation of newly appointed CDER director Richard Pazdur — one of the nation’s most influential cancer-drug regulators — signals deepening political interference inside the agency and could trigger further staff departures. In an interview with NewsNation, Peter Pitts, a former FDA associate
Biologics
Capricor Therapeutics says Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrophy (DMD), achieved statistically significant improvements in both skeletal muscle function and heart performance in the pivotal Phase 3 HOPE-3 trial. Data from the trial will support a response to a complete response letter (CRL)
Drugs
The FDA Accelerating Rare Disease Cures (ARC) program Year-Three Annual Report says there were 26 rare disease new drug approvals in calendar year 2024. That’s three fewer approvals than ARC reported in its Year-Two report for 2023. Other categories shown on the report’s Year-At-A-
Devices
The American Hospital Association (AHA) says it generally supports artificial intelligence (AI) policy frameworks that balance flexibility to drive market-based innovations with appropriate safeguards to protect privacy and patient safety. The association stated its position in response to an FDA request for comment on the measurement and evaluation of
Drugs
In the wake of CDER director Richard Pazdur’s abrupt resignation, reportedly over concerns of growing politicization at the agency, a new report now finds that two Republican lawmakers were barred from attending a 12/3 FDA meeting concerning the potential expanded approval of ImmunityBio’s Anktiva (nogapendekin alfa inbakicept-
Drugs
FDA has granted Eli Lilly traditional approval for Jaypirca (pirtobrutinib) and its use in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were previously treated with a covalent BTK inhibitor. The action is based on confirmatory trial data and converts a 2023 accelerated
Drugs
Veristat principal regulatory specialist John Kirk says sponsors looking to participate in the FDA Commissioner’s National Priority Voucher (CNPV) program will do best with the program’s compressed timelines (review in one to two months) if they integrate their biostatistics, regulatory, and medical writing teams from the outset, creating
Drugs
FDA has named physician–epidemiologist Tracy Beth Høeg as CDER acting director, replacing director Richard Pazdur, who submitted his retirement paperwork earlier this week. Høeg, who previously served as senior advisor for clinical sciences in both the Office of the Commissioner and CBER, was selected by FDA commissioner Marty Makary