All articles tagged with #fda oversight
ProPublica developed Rx Inspector, a tool that links generic drugs to their manufacturing facilities and FDA inspection histories, aiming to improve transparency and inform consumers and healthcare providers about drug safety and manufacturing practices.
A study of almost 200,000 newborns in Sweden and Norway found that maternal receipt of the COVID-19 vaccine during pregnancy poses no risk to infants and may prevent serious complications, with the mortality rate for babies born to vaccinated mothers being half the rate of those whose mothers were unvaccinated. Additionally, a new rapid point-of-care test for gonorrhea in South Africa showed high accuracy and rapid detection, potentially improving syndromic management of the infection. Data from three US cohort studies suggested that bivalent mRNA COVID-19 vaccines were 54% effective against lab-confirmed COVID infection and 49.4% protective against symptomatic disease in school-aged children. Meanwhile, a report highlighted weak FDA oversight of foreign firms making medications for the US market, with the FDA struggling to oversee more than 4,800 foreign drug manufacturers supplying medications for the US market.
An investigation by The Washington Post has revealed that the number of children affected by lead-tainted applesauce pouches is likely higher than official counts. The Food and Drug Administration (FDA) has received reports of 64 children who have suffered adverse events linked to the tainted cinnamon applesauce pouches, but state health and environment officials are investigating at least 118 confirmed or suspected cases in 31 states. The recall has raised concerns about the FDA's oversight of toxic metals in baby and toddler foods, as previous reports have found significant levels of lead, arsenic, cadmium, and mercury in these products. The investigation has also highlighted the need for stricter regulations and testing for heavy metals in baby food.