Department of Health and Human Services August 23, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) refusing to approve a new drug application (NDA) submitted by Intarcia Therapeutics, Inc., an i2o Therapeutics Business Unit, (Intarcia) for ITCA 650 (exenatide in DUROS device). FDA has determined that the approval criteria in the FD&C Act have not been met because Intarcia has failed to demonstrate that ITCA 650 is safe for its intended conditions of use.
Electronic Submission Template for Medical Device De Novo Requests; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Electronic Submission Template for Medical Device De Novo Requests." FDA is issuing this guidance to introduce submitters of De Novo requests to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA. This guidance is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Announcement of the Sixth Meeting of the 2025 Dietary Guidelines Advisory Committee
The Departments of Health and Human Services and Agriculture announce the sixth meeting of the 2025 Dietary Guidelines Advisory Committee (Committee). This meeting will be open to the public virtually.
Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to Coronavirus Disease 2019 (COVID-19). FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS), as amended on March 15, 2023, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA's website from the links indicated.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma and Esophageal Squamous Cell Carcinoma
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the 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.
Administration on Disabilities, The President's Committee for People With Intellectual Disabilities
The President's Committee for People with Intellectual Disabilities (PCPID) will host a meeting for its members to discuss the 2024 PCPID Report focused on Home and Community Based Services (HCBS) and discuss emerging issues facing people with intellectual disabilities. All the PCPID meetings, in any format, are open to the public. Members of the public can join in person or virtually. This meeting will be conducted in presentation and discussion format.
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