⚖️FDA Guidance on Evaluating Food Allergen Public Health Importance
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for FDA staff and interested parties entitled "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act." This guidance document provides our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than one of the major food allergens (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame) listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Learn More🧬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(FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled "Considerations for Including Tissue Biopsies in Clinical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).
Learn More🏥FDA Guidance on Donor Eligibility for Human Products Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance document entitled "Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." This draft guidance document includes general information on determining eligibility for donors of HCT/Ps. In addition, FDA intends to issue separate guidance documents with recommendations regarding reducing the risk of transmission of specific communicable disease agents and diseases for donors of HCT/Ps. These guidance documents are intended to update an existing guidance.
Learn More🧬FDA Guidance on Genomic Alterations in Food-Producing Animals
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #251 entitled "Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease." This draft guidance, when finalized, will set forth FDA's policy regarding heritable intentional genomic alterations (IGAs) in animals of food- producing species, such as swine and rabbits, that are intended to be marketed for use as models of human or animal disease in biomedical research under contained and controlled conditions. The draft guidance describes the conditions under which we generally may not expect developers of IGAs in animal models of disease to submit an application to FDA's Center for Veterinary Medicine (CVM) or to get our approval before marketing their animals following CVM's prior review of risk factor data.
Learn More🐾FDA Guidance on Type VII Veterinary Master Files for R&D Released
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." This draft guidance, when finalized, will describe FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs). Type VII VMFs are appropriate for research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), gene therapies, and heritable intentional genomic alterations (IGAs) in animals.
Learn More⚕️FDA Announces Draft Guidance for In Vitro Diagnostic Devices
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency." The draft guidance describes general recommendations for the validation of in vitro diagnostic devices (IVDs) for emerging pathogens during an applicable declaration of public health emergency. This guidance and the associated template include the recommendations that apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered as described in an applicable enforcement discretion policy. This draft guidance is not final nor is it for implementation at this time.
Learn More🦠FDA Guidance on Reducing Mycobacterium Tuberculosis Transmission Risks
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for immediate implementation entitled "Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." FDA is issuing this guidance to assist establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations for screening donors for evidence of, and risk factors for, infection with Mycobacterium tuberculosis (Mtb), the organism that causes tuberculosis. The guidance also recommends additional steps that HCT/P establishments should take to reduce risk of transmission of Mtb until such time as appropriate FDA-licensed, approved, or cleared donor screening tests are available for use to test donors for Mtb infection. The guidance identifies Mtb as a relevant communicable disease agent or disease (RCDAD) and supplements the recommendations contained in other donor eligibility guidance documents for donors of HCT/Ps. This guidance is being issued to address the urgent public health need to reduce the risk of transmission of Mtb by HCT/Ps.
Learn More⚖️FDA Guidance on Sex-Specific Data in Medical Device Studies
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Evaluation of Sex- Specific and Gender-Specific Data in Medical Device Clinical Studies." This document provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to determine the safety or effectiveness of a device. The purpose of this guidance is to encourage science- driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the device, when designing medical device clinical studies and reporting data from such studies in accordance with legal requirements. This draft guidance is not final nor is it for implementation at this time.
Learn More🩺FDA Draft Guidance on Reducing Disease Transmission Risks in HCT/Ps
The Food and Drug Administration (FDA or Agency) is announcing the availability of three specific draft guidances for industry entitled "Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" "Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" and "Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." These draft guidances are intended to update existing guidances and to assist establishments making donor eligibility determinations in understanding the requirements for determining donor eligibility, including donor screening and testing, for donors of HCT/Ps. These draft guidances are also intended to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of specific communicable disease agents and diseases, specifically, hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), by HCT/Ps.
Learn More🧬FDA Guidance on Heritable Genomic Alterations in Animals
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process." This guidance clarifies FDA's requirements and recommendations for developers of intentional genomic alterations (IGAs) in animals. The guidance is one of two companion documents. "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the FDA approval process applies to heritable IGAs in animals. The companion final guidance, GFI #187A entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach," describes FDA's risk-based regulatory approach to the oversight of heritable IGAs in animals.
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