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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 released three draft guidelines aimed at reducing the transmission risk of hepatitis B (HBV), hepatitis C (HCV), and HIV through human cells and tissues. These guidelines update previous recommendations to help organizations determine donor eligibility through proper screening and testing. Comments on these drafts are encouraged by February 6, 2025, and can be submitted electronically or in writing. The drafts also advise on eliminating certain donor screening questions and focus on assessing each donor's risk based on relevant factors, regardless of gender.

The Food and Drug Administration (FDA) has released a draft guidance for industry on the process of notifying them about a permanent discontinuance or an interruption in the manufacture of infant formula. This guidance aims to assist those in the infant formula industry in complying with notification requirements to the FDA, as mandated under the Federal Food, Drug, and Cosmetic Act. The guidance outlines how and when manufacturers should notify the FDA in order to avoid potential disruptions in supply. The public is invited to submit comments on the draft guidance until February 18, 2025, and on the proposed collection of information by February 3, 2025.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 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 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) 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 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) 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 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.