FDA Requests Public Comments to Inform Development of National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan for 2026-2030
January 8, 2025
The FDA released a request for comments soliciting public input on new opportunities and emergent monitoring needs for possible inclusion in the forthcoming National Antimicrobial Resistance Monitoring System (NARMS) 2026-2030 Strategic Plan. The Federal Register notice about the request includes instructions for submitting comments, as well as specific questions and requests for information meant to prompt helpful submissions. The agency will be accepting public comments through March 26, 2025.
Read more
FDA Launches New Supply Chain Website Content
January 16, 2025
The FDA works with HHS and other federal and state partners on a multi-pronged, all-of-government approach to address shortages of FDA-regulated products. See how the FDA monitors, prevents, and mitigates shortages and supply chain disruptions for FDA-regulated products and then check out information for industry and the latest news on supply chain issues.
View more
Vaccines for COVID-19: A Personal Reflection
January 13, 2025
COVID-19—the disease caused by the SARS-CoV-2 respiratory virus—has taken a terrible toll. The World Health Organization (WHO) estimates that COVID-19 is responsible for at least 1.2 million deaths in the U.S. and over 7 million deaths worldwide.1 Amid this catastrophic wave of death and remarkably severe illness, multiple emergency policies were enacted at every level of government and in private industry. In light of these impacts, we should engage in discussion and debate about those policies so that we can prepare effectively for the next pandemic. This essay is my personal reflection on the status of COVID vaccines, which constitute one of the most important elements of government policy, particularly as it relates to the U.S. Food and Drug Administration and my term as Commissioner.
Read more
|
FDA Issues Draft Guidance on Validation of In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency
January 6, 2025
Today, the FDA issued the draft guidance, "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency." This guidance, when finalized, will provide recommendations for validating certain in vitro diagnostic devices (IVDs) intended to detect new or unusual biological agents during a declared emergency applicable to IVDs under section 564 of the Federal Food, Drug, and Cosmetic Act. It applies to test data and information submitted in an Emergency Use Authorization (EUA) request, pre-EUA request, or to a test offered as described in an applicable enforcement discretion policy.
Read draft guidance
Final Guidance: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act
January 6, 2025
The FDA issued a final guidance, “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act”. Under section 506J of the FD&C Act, manufacturers are required to notify the FDA, during or in advance of a public health emergency, of a permanent discontinuance or interruption in the manufacturing of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States. This guidance provides information about notifications under section 506J during or in advance of any public health emergency. On Tuesday, March 4, 2025, the FDA will host a webinar for those interested in learning more about the guidance.
Read guidance
FDA Issues Guidances on Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) Regarding Donor Eligibility Determinations
January 6, 2025
The FDA issued four draft guidances and two final guidances on human cells, tissues, and cellular and tissue-based products (HCT/Ps) regarding donor eligibility determinations. The guidances, including the draft guidances when finalized, are intended to provide recommendations to establishments that make donor eligibility determinations and update existing FDA guidance on a number of related topics.
The guidances on donor eligibility determinations published this week include:
-
Recommendations for Determining Donor Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): This draft guidance is a general guidance intended to assist establishments in understanding the requirements for determining eligibility, including donor screening and testing.
-
Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); and Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products(HCT/Ps): These three draft guidances provide updated recommendations to reduce the risk of HIV, HBV, and HCV transmission, and include several updates to our existing recommendations, including the following:
- Revising recommendations for donor screening that includes reducing certain time-based risk factors and conditions; and
- Eliminating the HCT/P donor screening questions specific to men who have sex with men (MSM) and women who have sex with MSM and, instead recommending that establishments assess HCT/P donor eligibility using the same individual risk-based questions relevant to HIV, HBV, and HCV risk for every donor regardless of sex or gender.
-
Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); and Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): These final guidances are intended for immediate implementation, and provide recommendations to assist establishments in complying with certain regulatory requirements for donor eligibility determinations to reduce the risk of transmission of Mtb or infections due to sepsis.
Read more
Final Guidance: Advanced Manufacturing Technologies Designation Program
January 2, 2025
The FDA is announcing the availability of a final guidance for industry entitled “Advanced Manufacturing Technologies Designation Program.” FDA encourages the early adoption of advanced manufacturing technologies (AMTs) by the pharmaceutical industry, which can improve the reliability and robustness of the manufacturing process and can benefit patients by enhancing product quality and reducing drug development time or increasing or maintaining the supply of drugs that are life-supporting, life-sustaining, of critical importance to providing health care, or in shortage.
Read guidance
|
