HFS seeks members for new Medicaid beneficiary advisory council
The Department of Healthcare and Family Services is seeking members to serve on a new advisory council to help “shape future policy decisions” for the Medicaid program.
Mississippi opioid settlement council finalizes grant applications
Mississippi’s Opioid Settlement Fund Advisory Council has finalized and expects to soon release grant applications for the tens of millions of dollars it oversees, moving the state closer to using its settlement money to address addiction. The council held a make-up meeting in Jackson late Friday afternoon after a virtual session was derailed by hackers […]
Major Medical Groups Pushed Out of Role Supporting CDC’s Vaccine Advisors
Multiple healthcare organizations that have historically helped the CDC’s Advisory Committee on Immunization Practices (ACIP) develop vaccine recommendations have been told they can no longer participate in ACIP work groups, leaving the organizations frustrated and worried about what will happen next. “We’re very concerned and disheartened that our organizations are considered ‘special interest groups’ and […]
FDA Panel Votes Against Broad Talazoparib-Enzalutamide Label in Prostate Cancer
An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib (Talzenna) plus enzalutamide (Xtandi) for all patients with metastatic castration-resistant prostate cancer (mCRPC). In an 8-0 vote, members of the Oncologic Drugs Advisory Committee (ODAC) said the available data from the TALAPRO-2 trial do not support a favorable risk-benefit […]
FDA Advisory Panel Generally Pleased With Pulse Oximetry Clinical Trial Proposal
An FDA advisory committee gave generally high marks to the agency’s latest effort to improve the accuracy of pulse oximeters when used in darker-skinned patients, but raised questions about some of the FDA’s proposed premarket clinical trial guidance for pulse oximeter manufacturers. “I really applaud the efforts of the FDA to reduce disparate bias in […]
Critics Say CDC Advisors’ Infection Control Guidance Isn’t Strong Enough
A CDC advisory committee voted unanimously on Friday to approve draft infection control guidelines, though some critics charge the recommendations don’t go far enough and ignore lessons from the COVID-19 pandemic. At the heart of the controversy is a new “air” category for pathogen transmission, and three levels of air precautions based on how transmissible […]
Potential Cure for Sickle Cell Clears Hurdle for Approval
An FDA advisory committee meeting on Tuesday did nothing to dispel expectations that the investigational agent exagamglogene autotemcel (exa-cel) will become the first approved gene therapy for sickle cell disease (SCD). Members of the Cellular, Tissue, and Gene Therapies Advisory Committee were not asked to vote on the agent’s efficacy or safety, but instead directed […]
Sotorasib’s Confirmatory Data in NSCLC Unreliable, Says FDA Panel
An FDA advisory committee on Thursday said the confirmatory trial data for the KRAS inhibitor sotorasib (Lumakras) in previously treated non-small cell lung cancer (NSCLC) cannot be reliably interpreted in the CodeBreaK 200 study. Most members of the Oncologic Drugs Advisory Committee (ODAC) agreed with FDA staff that multiple sources of systemic bias during the […]
FDA Panel Endorses DFMO for Kids’ High-Risk Neuroblastoma in Remission
After wrangling all day over semantics and a potential precedent-setting dataset, an FDA advisory committee voted to recommend approval of eflornithine (difluoromethylornithine; DFMO) maintenance for high-risk pediatric neuroblastoma in complete remission after standard therapy. By a 14-6 vote, the Oncologic Drugs Advisory Committee (ODAC) decided that the totality of evidence presented was sufficient to show […]
FDA Advisors Grapple With Logistical, Ethical Issues of Artificial Womb Technology
While members of the FDA Pediatric Advisory Committee (PAC) said much of the existing artificial womb technology (AWT) research is promising, they noted that the logistical and ethical concerns previously raised by the agency’s staff members are complicated. The committee did not vote during their 2-day meeting this week. Further discussion about first-in-human trials for […]