FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies
The application could not be approved in its present form due to manufacturing deficiencies.
The application could not be approved in its present form due to manufacturing deficiencies.
Proposal would create a category of hearing aids that could be sold directly to consumers, without medical exam or audiologist fitting
Cumulative incidence highest in patients aged 5 years and younger; factors that influence development include cumulative dose of cisplatin
The application is supported by data from 2 pivotal open-label, randomized phase 3 trials (SIOPEL 6 and ACCL0431), which compared the efficacy of sodium thiosulfate plus cisplatin to cisplatin alone for the prevention of cisplatin-induced hearing loss.
By using smartphone microphone, speaker to assess eardrum mobility, app can detect middle ear fluid
Overall, 14.2% of all children had audiometric notches and high-frequency hearing loss; 4.5, 7.6, and 2.1% fulfilled the criteria of a notch, high-frequency hearing loss, and both, respectively.
The Clinical Oncology Group Protocol ACCL0431 trial enrolled 125 pediatric patients newly diagnosed with a germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
Older age at menopause also appears to increase the risk