Search Results for keywords:"FDA guidance"

The Food and Drug Administration (FDA) has made available a final guidance document titled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates a previous version and includes a list known as the 506J Device List, which outlines device product codes that manufacturers must notify the FDA about if they stop production. The document clarifies that manufacturers can also voluntarily notify the FDA of any supply chain issues, regardless of public health emergencies. This guidance aims to facilitate continuous device supply and prevent shortages.

The Food and Drug Administration (FDA) has released a final guidance document on marketing submissions for devices with artificial intelligence-enabled software. This guidance provides recommendations for including a Predetermined Change Control Plan (PCCP) in submissions, which outlines planned AI software modifications, their development and validation, and their potential impact. The FDA aims to streamline the approval process for such modifications by avoiding repeated marketing submissions while ensuring device safety and effectiveness. The guidance reflects the FDA's efforts to regulate AI-enabled medical device software innovatively and effectively.

The Food and Drug Administration (FDA) has announced the release of draft guidance titled "Developing Drugs for Optical Imaging."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 announced the availability of a final guidance titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance details FDA's temporary rules for licensed pharmacists and physicians who are compounding drugs using bulk substances, while the agency works on creating a list of approved substances. The updated guidance finalizes the draft that was issued in December 2023 and replaces the previous 2017 guidance, ending the categorization of substances into different groups and outlining conditions under which the FDA will not take action against compounding that does not meet full compliance, while the list is still being developed. This guidance is issued as part of FDA's regulatory framework, but it does not establish any binding rights or obligations.

The Food and Drug Administration (FDA) has announced the release of a final guidance document titled "Mouse Embryo Assay for Assisted Reproduction Technology Devices." This guidance provides recommendations on conducting the mouse embryo assay (MEA), which is used to evaluate the potential for embryotoxicity of devices that come into contact with gametes and/or embryos. The FDA has revised the guidance based on public comments and has made several technical clarifications. The document emphasizes that following FDA guidelines is not mandatory and alternative approaches are acceptable if they meet relevant requirements.

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.

The Food and Drug Administration (FDA) released new guidelines for testing alcohols like ethanol and isopropyl alcohol for methanol contamination, especially during the COVID-19 pandemic. The guidance alerts pharmaceutical manufacturers and pharmacists about the dangers of using methanol-contaminated alcohols in drug products, which can pose significant health risks. Due to the urgent health emergency, these guidelines were issued without prior public comment and are immediately effective, although they can still receive comments for future updates. The guidance aims to ensure the safe use of pharmaceutical alcohol by focusing on proper identity testing and supply chain oversight.

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 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.