Search Results for keywords:"FDA guidance"

The Food and Drug Administration (FDA) is releasing draft guidance on studying sex differences in the clinical evaluation of medical products. This guidance aims to improve the representation of females in clinical trials and provide recommendations for analyzing sex-specific data. It highlights the importance of understanding different responses to treatments based on sex to improve safety and effectiveness. The public is encouraged to submit comments on this draft guidance by April 7, 2025.

The Food and Drug Administration (FDA) has released final guidance on limiting lead in processed foods for babies and young children under 2 years old. The guidance sets specific action levels for lead: 10 parts per billion (ppb) for most foods, and 20 ppb for certain root vegetables and dry infant cereals. These levels help ensure food safety and reduce lead exposure in the food supply. Interested parties can comment on the guidance, and it becomes available on several FDA websites.

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 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 Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Considerations for Complying With 21 CFR 211.110." This draft guidance aims to help manufacturers ensure the uniformity and integrity of drug products by complying with specific regulations. It also provides insight into how advanced manufacturing techniques, like 3D printing and continuous manufacturing, can be incorporated into manufacturing processes. The FDA encourages industry representatives who are interested in using innovative control strategies to contact them for further guidance.

The Food and Drug Administration (FDA) has released a draft guidance document titled "Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria". The guidance suggests that blood establishments test blood donations from donors at risk for malaria using an FDA-approved test. This draft, which aims to update recommendations from December 2022, is open for comments until March 17, 2025. The guidance is not legally binding and allows for alternative approaches that meet legal requirements.

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 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 document for the industry titled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” This document establishes the conditions for compounding certain drugs and explains the FDA’s current approach while developing a list of bulk drug substances permitted for use. This guidance replaces a previous version from 2017 and provides instructions on submitting comments to the FDA. The guidance clearly states it is not legally binding but shows the FDA's current thinking on this issue.