⚖️FDA Requests Nominations for Radiation Safety Advisory Committee Members
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective January 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.
Learn More💊FDA Renews Antimicrobial Drugs Advisory Committee Through 2026
The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Antimicrobial Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Antimicrobial Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 7, 2026, expiration date.
Learn More🏥FDA Seeks Comments for NARMS 2026-2030 Strategic Plan
The Food and Drug Administration (FDA, we, or Agency) is soliciting comments from the public regarding the National Antimicrobial Resistance Monitoring System (NARMS) 2026-2030 Strategic Plan. Comments received will help inform the development of a draft 2026-2030 Strategic Plan, to be discussed at a public meeting in spring 2025. Specific questions and information requests are included in this notice to help guide input from interested parties.
Learn More💊FDA Issues Priority Review Voucher for CRENESSITY (Crinecerfont)
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that CRENESSITY (crinecerfont), approved on December 13, 2024, manufactured by Neurocrine Biosciences, Inc., meets the criteria for a priority review voucher.
Learn More💊FDA Approves ALYFTREK Under Pediatric Disease Priority Program
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the application for ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor), approved December 20, 2024, meets the criteria for redeeming a priority review voucher.
Learn More🚫FDA Denies Hearing; Jiao Debarred for Five Years from Drug Imports
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Yong Sheng Jiao, also known as Yongsheng Jiao and Wilson Jiao (Jiao), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jiao for 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Jiao was convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance under the FD&C Act. In determining the appropriateness and period of Jiao's debarment, FDA considered the relevant factors listed in the FD&C Act. Jiao submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Learn More❌FDA Withdraws Notice on Yong Sheng Jiao's Debarment Order
The Food and Drug Administration (FDA) is issuing this notice to withdraw the December 5, 2024, Federal Register notice entitled "Yong Sheng Jiao; Denial of Hearing; Final Debarment Order" because the document provided the incorrect bases for debarment and omitted edited language. A corrected notice document is published elsewhere in this Federal Register.
Learn More🏥FDA Announces Guidance on Developing Obesity Treatment Drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction." This draft guidance provides recommendations to industry regarding the development of drugs and biological products regulated within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or overweight. This draft guidance revises and replaces the draft guidance for industry "Developing Products for Weight Management" issued in February 2007.
Learn More🩺FDA Draft Guidance on Developing Drugs for Optical Imaging
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing Drugs for Optical Imaging." The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that support development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for the detection of pathology such as tumors or to enhance the conspicuity of normal anatomical structures.
Learn More📄FDA Draft Guidance on AI-Enabled Device Software Functions
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations." This draft guidance, when finalized, will provide recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA's evaluation of safety and effectiveness. To support the development of appropriate documentation for FDA's assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI- enabled devices that sponsors may wish to consider using throughout the total product lifecycle (TPLC). This draft guidance is not final nor is it for implementation at this time.
Learn More