Department of Health and Human Services September 19, 2022 – Federal Register Recent Federal Regulation Documents

The U.S. Department of Health and Human Services' Office on Women's Health (OWH) is providing notice of a virtual Hypertension Summit focused on innovations and evidence to bridge practice gaps in the field of hypertension treatment and prevention. The purpose of the Hypertension Summit is to exchange information about this topic and seek input on an individual basis from: patients who have benefited from innovative approaches to treating hypertension; subject matter experts; Phase 1 awardees of the HHS Hypertension Innovator Award Competition; and members of OWH's Self-Measured Blood Pressure Program (SMBP). This Hypertension Summit will highlight research from the Women's Health Initiative that impacts heart health and women's health. This Hypertension Summit is open to the public. Individuals interested in attending this Hypertension Summit must register to attend as instructed below.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) has determined that ENDEP (amitriptyline hydrochloride) oral concentrate, 40 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting applications from patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum coordinated through the Office of Patient Affairs, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner at FDA, and is hosted by CTTI. Through the PEC, the patient community and regulators are able to discuss an array of topics regarding increasing meaningful patient engagement with diverse populations in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patient and patient advocate perspectives are incorporated into general medical product development and regulatory processes.