On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more
Report Submission and Review Pre-Submission Review is Not Required Applicable manufacturers may voluntarily provide covered recipients the opportunity to review the data prior to submission to CMS, but doing so is not...more