Search Results for keywords:"FDA guidance"

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” This guidance is aimed at describing how the FDA interprets the term "underway" in relation to confirmatory drug trials required after a drug has been granted accelerated approval. These trials are crucial for verifying the drug's effects on serious health conditions. The FDA is inviting the public to comment on this draft guidance by March 10, 2025, as part of their ongoing approval process requirements.

The Food and Drug Administration (FDA) has released a final guidance document titled "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 outlines how the FDA plans to assess the public health significance of food allergens not already classified as major allergens, like milk or peanuts. It focuses mostly on allergies caused by IgE antibodies known to trigger severe allergic reactions. The FDA also made updates in response to feedback, including changes related to non-IgE-mediated allergies and new data references.

The Food and Drug Administration (FDA) has released a final guidance for the cosmetic industry titled “Registration and Listing of Cosmetic Product Facilities and Products.” This guidance aims to help companies with the registration and listing process required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). It includes a draft section in Appendix B with new questions and answers, open for public comment. The guidance underscores that small businesses are exempt from these regulations and invites comments to be submitted by January 13, 2025.

The Food and Drug Administration (FDA) has released a new guidance to help reduce the risk of transmitting Mycobacterium tuberculosis (Mtb) through human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance provides recommendations for screening donors to check for signs and risk factors of tuberculosis infection. This document was issued urgently due to recent multistate outbreaks linked to Mtb transmissions from donors and aims to enhance screening until official tests are available. Although the guidance is effective immediately, the FDA is open to receiving comments on it.

The Food and Drug Administration (FDA) has released revised guidance for industries regarding food allergen labeling, as outlined in the Federal Food, Drug, and Cosmetic Act, incorporating updates from both the Food Allergen Labeling and Consumer Protection Act of 2004 and the Food Allergy Safety, Treatment, Education, and Research Act of 2021. This guidance specifically addresses labeling guidelines for allergens like sesame, milk, and eggs, and explains how to handle certain additives and oils in labeling. The FDA emphasizes that while the guidance reflects current FDA thinking, alternative compliance methods are allowed if they meet legal requirements. Public comments on this guidance are welcome and can be submitted electronically or in writing. The guidance is publicly accessible online.

The FDA has released a final guidance document for industry titled "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers." This guidance outlines the FDA's policy on how companies can share scientific information about unapproved uses of approved medical products with healthcare providers. This communication should be truthful and help healthcare providers understand the information's strengths and weaknesses. The guidance, which will not be implemented until the Office of Management and Budget approves related information collection activities, is designed to ensure that such communications are done in a responsible manner.

The Food and Drug Administration (FDA) has released a final guidance document titled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." This guidance aims to help manufacturers of tobacco products ensure that their testing methods for ingredients, constituents, and additives are consistent, reliable, and suitable for regulatory submissions. The document outlines best practices in analytical testing, including validation and verification of methods, which are crucial for regulatory compliance concerning new and modified risk tobacco products. The guidance also incorporates feedback from a draft issued in December 2021 and emphasizes the use of standard analytical methods.

The Food and Drug Administration (FDA) has announced the release of draft guidance titled "Developing Drugs for Optical Imaging." This guidance aims to provide advice to drug sponsors on designing clinical trials to develop and approve optical imaging drugs used with imaging devices during surgeries. Optical imaging drugs help surgeons identify tumors and differentiate them from normal tissue, enhancing surgical safety and effectiveness. Public comments on the draft can be submitted until April 8, 2025, although feedback is welcomed anytime.

The Food and Drug Administration (FDA) has released a final guidance document titled "Heritable Intentional Genomic Alterations in Animals: The Approval Process." This guidance outlines the FDA's requirements and recommendations for developers working on genetic changes in animals that can be passed down to future generations. The document explains how the FDA evaluates and approves these genetic alterations, addressing concerns such as animal health and food safety. The announcement also notes that the public can submit comments on this guidance through various methods, as described in the Federal Register notice.

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance titled “Considerations for Including Tissue Biopsies in Clinical Trials.” This document offers advice on implementing tissue biopsies in clinical trials, whether conducted on adults or children, especially when evaluating investigational medical products supported by the Department of Health and Human Services (HHS). It emphasizes that while biopsies can pose risks, they can be vital for certain trial evaluations, and often, participation in such biopsies should be optional if they serve exploratory or non-essential purposes. The guidance is open for public comment until March 10, 2025.