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📋FDA Guidance on Accelerated Drug Approval and Confirmatory Trials

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." For drugs granted accelerated approval, sponsors conduct confirmatory studies that must be completed postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. This draft guidance describes FDA's interpretation of the term "underway" and discusses policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.

🧬FDA Guidance on Tissue Biopsies in Clinical Trials for Businesses

The Food and Drug Administration (FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled "Considerations for Including Tissue Biopsies in Clinical Trials." This guidance provides recommendations regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS).

🏥FDA Seeks Nominations for National Mammography Advisory Committee

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective February 1, 2025, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

🔐Proposed HIPAA Security Rule Enhancements for Cybersecurity Compliance

The Department of Health and Human Services (HHS or "Department") is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Security Standards for the Protection of Electronic Protected Health Information ("Security Rule") under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The proposed modifications would revise existing standards to better protect the confidentiality, integrity, and availability of electronic protected health information (ePHI). The proposals in this NPRM would increase the cybersecurity for ePHI by revising the Security Rule to address: changes in the environment in which health care is provided; significant increases in breaches and cyberattacks; common deficiencies the Office for Civil Rights has observed in investigations into Security Rule compliance by covered entities and their business associates (collectively, "regulated entities"); other cybersecurity guidelines, best practices, methodologies, procedures, and processes; and court decisions that affect enforcement of the Security Rule.

💼NIH Closed Meeting Notice on Grant Applications – January 2025

💼Proposed Regulations on Excise Tax for Designated Drugs

This document contains proposed regulations relating to the excise tax on certain sales of designated drugs by manufacturers, producers, and importers during statutorily defined periods. The proposed regulations would provide substantive rules that relate to the imposition and calculation of the tax. The proposed regulations would affect manufacturers, producers, and importers of designated drugs that sell such drugs during statutorily defined periods.

📄CMS Notice on Information Collection Activities

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

📊Correction Notice for Child Welfare Services State Grants Allotment

The Administration for Children and Families published a document in the Federal Register published Wednesday, December 4, 2024, concerning notice of Allotment Percentages to States for Child Welfare Services State Grants. The formula used to calculate the allotment percentages for each state was not applied correctly. Although the percentage for the State of Alabama percentage was calculated correctly, the formula used to calculate the allotment percentages was not correctly applied to the remaining states.