Search Results for keywords:"guidance for industry"

The Food and Drug Administration (FDA) is reopening the deadline for public comments on a draft guidance for industry titled "Type VII Veterinary Master File for Research and Development and Risk Reviews." Originally, comments were due by March 10, 2025, but the FDA has extended the period by 60 days, allowing comments to be submitted until June 9, 2025. This extension responds to a request for more time to provide thorough feedback before the FDA finalizes the guidance. Comments can be submitted electronically via regulations.gov or as paper submissions to the Dockets Management Staff in Rockville, MD.

The Food and Drug Administration (FDA) has announced the availability of a final guidance titled "Animal Food Ingredient Consultation (AFIC)." This guidance outlines the AFIC process, which provides a new way for firms to consult with the FDA about developing animal food ingredients. The AFIC process aims to help the FDA identify any safety concerns with these ingredients and allows for public input. The guidance also explains FDA's enforcement policy for ingredients reviewed under the AFIC process and replaces the previous system with the Association of American Feed Control Officials (AAFCO), which ended on October 1, 2024.

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 released new guidelines for companies submitting information electronically related to drug and biologic license applications. This guidance helps ensure that data is submitted in a standardized format, which the FDA uses to plan and conduct inspections of research sites, known as Bioresearch Monitoring (BIMO) inspections. The guidance also clarifies which trials need to include certain information, aiming to enhance the FDA's inspection process for safety and efficacy claims in drug applications. Additionally, the guidance addresses previous technical issues and provides updated instructions for submissions under specific FDA regulations.

The Food and Drug Administration (FDA) has released a draft guidance titled "Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices." This document aims to help sponsors, clinical investigators, and institutional review boards define, identify, and report protocol deviations effectively during clinical investigations. It offers definitions and a classification system for reporting these deviations, allowing consistent documentation and interpretation. Comments on the draft can be submitted electronically or in writing by February 28, 2025, to help shape the final guidance.

The Food and Drug Administration (FDA) has released draft guidance to accelerate the approval process for drugs and biologics meant for serious or life-threatening conditions. This expedited program aims to quickly develop and review drugs that address unmet medical needs. The draft outlines the criteria for accelerated approval, including surrogate endpoints and confirmatory trials, and introduces procedures for rapidly withdrawing approvals if necessary. The public can submit comments on this draft by February 4, 2025, and share thoughts on the expedited withdrawal procedures and other aspects of the accelerated approval process.