CVM works with the sponsor to set up a pre-submission conference. Information exchange continues throughout the research and development process. The technical sections include target animal safety and effectiveness, manufacturing methods and control chemistry, residue chemistry and regulatory methods, human food safety, and environmental safety. Routine postmarket surveillance activities and special surveys are conducted to assure that sponsors are in compliance with regulations intended to ensure data integrity and good manufacturing practices. Pre-approval inspections are conducted when needed, to enhance understanding and confirm that the sponsor has the ability to produce a safe and effective product.
Research is an essential element in the approval process.
Method validation studies are necessary in approving applications for new drugs for food animals. In addition to methods validation, analytical methods development research improves the effectiveness of surveillance activities by providing more rapid and accurate procedures to detect and quantitate chemical substances in foods. Information system development improves the ability of primary reviewers to access Agency and sponsor data used in the review process. New Animal Drug Review activities are supported by scientific research, data collection, and analysis. Scientists provide guidance and assistance to industry, consumers, and other constituencies regarding regulatory interpretations related to animal drugs and feeds.