The US Department of Health and Human Services (HHS) has published its semiannual regulatory agenda that includes rules the Food and Drug Administration (FDA) plans to propose or finalize in the near future, as well as several longer-term efforts. The agenda lists more than 10 rules that would affect drugmakers, medical device manufacturers and patients.
In total, HHS listed 21 rules that fall under FDA’s purview, including eight planned proposed rules, eight final rules, four long-term actions and one completed action; this includes rules that cover other FDA-regulated products such as food and tobacco.
“The purpose of the agenda is to encourage more effective public participation in the regulatory process,” said HHS. “The regulatory actions forecasted in this agenda reflect the priorities of HHS Secretary Xavier Becerra and the Biden-Harris Administration.”
HHS noted that the agenda also contains rulemaking to address the COVID-19 pandemic, expand access to health care, address health disparities and improve mental health.
Among the rules in the proposal stage is a rule that would amend FDA’s medication guide regulations to require a new form of patient labeling called Patient Medication Information. The labeling requirement would apply to drugs and certain blood products to make drug labels easier to understand by consumers…
