Stakeholders interested in the new animal drug approval process are invited to attend a U.S. Food and Drug Administration conference on July 17 in Silver Spring, Maryland.
The Animal Drug User Fee Act was signed into law in 2003 and most recently was reauthorized by Congress in 2023. The statute allows the FDA to charge fees for certain new animal drug applications, products, establishments and sponsors. The money helps fund the agency’s drug review process.
The conference, the first of five, will provide information about:
- The animal drug approval process.
- The communication pathways within the FDA’s Center for Veterinary Medicine.
- Approval process best practices.
- Overview of the animal safety technical section; effectiveness technical section; and chemistry, manufacturing and controls technical section.
- Human food safety.
- Environmental impact.
The conference, which will include a question-and-answer session, is open to the public and may be attended virtually or in person. Registration is available at bit.ly/4coG3f8.
The FDA asks in-person attendees to register by July 10. Virtual attendees can register at any time.