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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 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) 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 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.