FDA Policy/General
Rep. Nikema Williams (D-GA) and three other legislators have introduced the Plain Prescription Prices Act that would require direct-to-consumer TV ads for prescription drugs to include a statement of the drug’s list price. In a statement, Williams says the legislation “will empower consumers to hold drug
Drugs
Pennsylvania attorney general Dave Sunday says his state is expected to receive $1.28 million as its share of a $202 million settlement that 49 attorneys general reached with Gilead Sciences for running an illegal kickback scheme to promote its HIV medication. In a statement, Sunday says, “Gilead violated federal
Drugs
As FDA moves forward with efforts to reauthorize the Prescription Drug User Fee Act, the Center for Science in the Public Interest (CSPI) asks the agency to consider that congressional appropriations should be the primary source of its funding. In its 7/17 comment letter, CSPI says it supports an
Biologics
HHS secretary Robert F. Kennedy, Jr. has signed off on a new federal directive removing thimerosal, a mercury-based preservative, from all influenza vaccines distributed in the U.S. The action formally adopts a recommendation made by CDC’s Advisory Committee on Immunization Practices (ACIP) during a 6/25-26
Drugs
FDA says up to five drug and biologic developers will be selected in the first year to participate in the Commissioner’s National Priority Voucher pilot program. An agency statement solicits statements of interest in the pilot that will offer these benefits: * faster review times (1-2 months rather than
Drugs
Researchers from the University of Pennsylvania and the University of Southern California say that members of the FDA Oncology Drugs Advisory Committee (ODAC) reported that very few questions posed by the agency for committee votes were difficult to answer. Writing in JAMA Network Open, the researchers say there has been
Drugs
The CDER Center for Clinical Trial Innovation has published a white paper, “Selective Safety Data Collection,” which is defined as the planned reduction in the collection of certain types of data in a clinical investigation for drugs with a well-characterized safety profile. The document describes the FDA 2016 guidance
Biologics
FDA has extended by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The new user fee review action target date is 10/23, which is intended
Drugs
Apnimed is announcing positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin and atomoxetine), a once-daily oral pill for treating obstructive sleep apnea (OSA). The company says the LunAIRo study met its primary endpoint, reinforcing earlier findings from the SynAIRgy trial, moving it one step
FDA Policy/General
Former and current FDA employees who have used the agency’s new internal generative artificial intelligence (AI) tool Elsa report that it can’t be trusted. An online Gizmodo post says three employees told CNN that Elsa makes up nonexistent studies, something commonly referred to in AI as “hallucinating.” The
Devices
Baxter Healthcare has recalled (Class 1) a mobile lift component used in several patient lift devices due to the risk of improper attachment. The company says that the Q-link 13 component could allow for false latching of the quick-release hook used on sling bars and other accessories. “The
Drugs
The Congressional Budget Office (CBO) says a nine-month increase in FDA review times for NDAs would reduce the number of FDA-approved drugs in the first year following the increase. The CBO analysis was in response to a request from Democratic leaders of four House and Senate committees with
Devices
FDA has issued an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump, following reports of underinfusion, overinfusion, and two patient deaths. According to Baxter, the device may deliver insufficient medication or fluids when transitioning from a lower to a significantly higher flow
Drugs
FDA researchers say 99.7% of good clinical practice (GCP) inspections conducted from 2017 to 2023 were classified as either NAI (no action indicated) or VAI (voluntary action indicated), and their recommendations and final classifications remained highly congruent. Writing in the open-source Therapeutic Innovation & Regulatory Science, the researchers
Biologics
An 8/23-8/31/2023 FDA inspection at the O3UV facility in Grand Ledge, MI, documented multiple violations in the firm’s illegal manufacturing of autohemotherapy devices. A 7/7 Warning Letter says the firm’s products are adulterated because the company does not have an approved PMA or
Drugs
A 2/3-2/14 FDA inspection at the Glenmark Pharmaceuticals Limited drug manufacturing facility in Pithampur, Madhya Pradesh, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/11 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy
Biologics
FDA has rejected a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec). In a just-issued complete response letter, the agency said it could not approve RP1 in combination with nivolumab due to concerns about the clinical trial data. According to Replimune, FDA found the pivotal IGNYTE
Biologics
FDA has won its regulatory battle (see earlier story) against gene therapy maker Sarepta Therapeutics. Late last evening (7/21) the company announced that it will agree to FDA’s request to pause all shipments of Elevidys (delandistrogene moxeparvovec) for Duchenne muscular dystrophy in the U.S. “This proactive step
Drugs
A Center for Medicine in the Public Interest (CMPI) report says FDA regulatory failures in enforcing limits on GLP-1 compounding put patients at risk. The report was written by former FDA associate commissioner Peter Pitts, CMPI president. Pitts says a temporary shortage of the GLP-1 drugs that have
Biologics
Laura Loomer, a far-right influencer and conspiracy theorist, has it out for CBER director Vinay Prasad. Loomer, who often has president Trump’s ear and influenced the ouster of a number of “disloyal” Trump officials and aides, now has her sights on Prasad, who she says should be removed
Devices
Maquet Critical Care AB, a subsidiary of Getinge, is recalling (Class 1 device correction) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate compliance measurement leading to improper tidal volume delivery in neonatal patients. The devices can be used with several different patient circuits
Drugs
FDA has named Stanford pediatrics (neonatology) adjunct professor George Tidmarsh, an industry veteran for over 30 years, as the new CDER director. Tidmarsh is replacing former Center director Patrizia Cavazzoni, who left the agency in the early days of the Trump administration and has since returned to her industry roots