Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #234 entitled "Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications." In order to improve the process for submission and review of chemistry, manufacturing, and controls (CMC) information for animal drugs, the Center for Veterinary Medicine (CVM) has developed a series of questions that focus on the critical scientific and regulatory issues and pharmaceutical attributes essential for ensuring the quality of new animal drug substances and products. Termed Question-based Review (QbR), these questions provide a general framework for original CMC submissions to investigational new animal drug (INAD) files, generic investigational new animal drug (JINAD) files, new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), conditional approval of applications for conditional approval (CNADAs), and veterinary master files (VMFs).