FDA Drug Application Costs Will Rise by About $300,000 in 2025
The FDA announced that the cost of filing a drug using clinical data will increase by about $300,000 in 2025 to $4.3 million, according to Pharmaceutical Technology. Yesterday, the agency released the federal docket, “Prescription Drug User Fee Rates for Fiscal Year 2025,” outlining the new fees that pharmaceutical companies will face following clinical trials to possibly get market access. It reported that filing for approval with clinical data will cost $4.3 million. However, an application that does not require clinical data will cost just under $2.2 million. Therefore, these costs increased by about $300,000 for a clinical data application, which cost $4 million in 2024; the costs increased by about $150,000 for an application that does not require clinical data, which cost $2 million in 2024. The new fees go into effect on October 1, 2024, and will remain so until September 30, 2025.
Child Suicide Rates Have Continued to Climb in the Past 15 Years, Study Finds
A recent study found that the suicide rate among US children aged between 8 to 12 years, also known as preteens, has steadily risen during the past 15 years, with a disproportionate increase among girls, according to The Washington Post. Between 2001 and 2022, 2241 preteens died by suicide; suicide rates increased by about 8% annually from 2008 to 2022. The researchers noted that 482 preteens died by suicide at a rate of 3.34 per 1 million preteens from 2001 through 2007. However, the number of suicides among preteens rose to 1759 from 2008 to 2022, with a rate of 5.71 per 1 million preteens. Although boys have a higher suicide rate than girls, suicide among preteen girls has disproportionately increased in the past 15 years; the rate of suicide for preteen girls was 1.25 per 1 million from 2001 through 2007 and rose to 4.15 per 1 million between 2008 and 2022. Although the researchers did not blame a specific reason for the increase, experts uninvolved with the study say the problem is multifaceted, identifying social media, technology, and social media as the main causes.