In a May 8 Senate hearing, U.S. FDA commissioner Bob Califf described the agency’s advisory committee process as a useful source of information, but Califf reassured members of the Senate that the FDA is not intent in doing away with advisory hearing votes altogether.
The U.S. FDA finalized a guidance for third-party servicing of medical devices, which helps to clarify the distinction between servicing and remanufacturing of a device. However, the most significant change from the draft guidance is that the agency openly declared that it will inspect these independent services organizations, a dramatic shift from the agency’s previous formal stance on these entities.
Field Medical Inc. kicked off its first-in-human study for its Fieldforce ablation system, designed for use in ventricular arrhythmias. The Ventricular Catheter Ablation Study study will enroll 60 patients in five centers around the world, most recently kicking off in the Na Homolce Hospital in Prague, Czech Republic.
The latest patent filing from Cranius LLC describes a reservoir for its implanted drug delivery devices which is shaped and formed to empty and fill reliably without any concern for neighboring organ impingement or compression, and which can precisely control and monitor exactly just how much of a medicine is being delivered.
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
In a May 8 Senate hearing, U.S. FDA commissioner Bob Califf described the agency’s advisory committee process as a useful source of information, but Califf reassured members of the Senate that the FDA is not intent in doing away with advisory hearing votes altogether.
This time a positive result for a cancer screening test brought good news, as Geneoscopy Inc. secured U.S. FDA approval for its RNA screening test for colorectal cancer. The agency based its decision on strong results from the phase III CRC-PREVENT trial in its approval of the noninvasive test for use in individuals aged 45 years and older with average risk for the disease.
The theft of 110 units of a study drug containing a Schedule III controlled substance resulted in a warning letter from the U.S. FDA. Addressed to the clinical investigator, Kevin Bender, of the Tamarac, Fla.-based DBC Research Corp., the May 2 letter should serve as a reminder to all trial investigators handling controlled substances.
The bifunctional antibody approach continues to pay off for Zenas Biopharma Inc., which banked an upsized $200 million series C preferred stock financing led by SR One along with NEA, Norwest Venture Partners and Delos Capital. Enavate Sciences and Longitude Capital participated significantly as well.
Researchers from the University of Pittsburgh have developed a device designed to collect exhaled respiratory aerosols from mechanically ventilated patients. Their device is designed to be non-invasive, highly efficient and can be readily placed in the exhalation line of ventilators without interfering in the functions of the ventilator.
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