Guidelines

Earlier this year, the United States Department of Health and Human Services (HHS) issued guidance to explain how audio-only…

On August 25, 2022, Blood Advances published a new study, authored by Ruemu Birhiray, MD and his daughter, Maya Birhiray, BS, that…

On August 4, 2022, the US Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking to reinterpret…

Metastatic pancreatic cancer is a serious malignancy that, with limited treatment options and poor outcomes, poses a growing…

On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which…

In early March 2022, the United States Food and Drug Administration (FDA) finalized guidance to help regulated industries (i.e.,…

Earlier this year, the United States Food and Drug Administration (FDA) published a final guidance, “Principles of Premarket…

In late January 2022, the United States Food and Drug Administration (FDA) issued three guidances (two final and one revised…

At the end of 2021, the United States Food and Drug Administration (FDA) issued two draft guidance documents that outline the…

In mid-November 2021, several government agencies released a joint interim final rule with request for comments that requires…