For several years, FDA has advanced a policy of increasing diversity in clinical trial populations. During that time, FDA issued broad policy statements, as well as guidance on improved data collection and steps sponsors...more
In 2021, the Department of Justice (DOJ) obtained more than $5.6 billion in False Claims Act settlements and judgments — the largest amount since 2014 and the second largest amount recorded. This number is inflated by the...more
Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after the study’s primary completion date. In the past, some companies delayed updating a clinical...more