Experts say that for the public to have confidence in medicines, regulators must be completely open about drug safety. According to a study that was recently published in The BMJ, less than one-third of the regulatory decisions made by the US Food and Drug Administration (FDA) are supported by publ
The study indicates that either the FDA is basing its regulatory decisions on information that has not been made publically accessible or that when possible safety signals are identified, more thorough safety evaluations may be required.
Monitoring a medicine’s safety after it is made accessible to patients is critical for monitoring drug safety. A team of US researchers, therefore, decided to analyze safety signals identified within the FAERS database. They asked how often these signals resulted in regulatory actions and whether they were corroborated by additional research.
However, less than a third of regulatory actions were corroborated by at least one relevant published research study, and none of the regulatory actions were corroborated by a public assessment, reported by the Sentinel Initiative. In a linked editorial, experts argue that regulators should publish all evidence underlying their responses to drug safety signals to reduce harm and ensure public trust in medicines.
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Deaths from Alcohol Up Nearly 30 Percent During First Year of PandemicGovernment data shows deaths due to alcohol spiked nearly 30 percent in America during the first year of the coronavirus pandemic, a time that also caused anxiety and depression.
Read more »
Brown has 30, Celtics hit 27 3s in 133-118 win over KnicksThe Celtics made a franchise-record 27 3-pointers in a victory over the Knicks on Saturday night.
Read more »
UL Monroe comes from 21 down to beat Texas State, 31-30MONROE, La. — Malik Jackson scored on a 3-yard run early in the fourth quarter to give...
Read more »
We Tested 11 Models (and Cooked 30 Pounds of Potatoes) to Find the Best Air FryersWe tested 11 popular air fryers to find the ones that made consistently crispy, well-browned food and were easy to use and clean.
Read more »