This cluster supports the Agency's premarket review goal area, specifically the strategies of informing and assisting product sponsors and streamlining reviews. Information dissemination is critical to the successful implementation of the ADAA and our REGO initiatives and the development of a collaborative atmosphere which benefits drug sponsors, FDA reviewers, taxpayers, and the general public. Resources are primarily devoted to new animal drug review, but also include surveillance activities in the field and research that supports the review process. A sponsor notifies CVM about the development of a new animal drug. 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.