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Recording: Excipient Considerations in the Development and Approval of Animal Drug Products

Part 1: Tuesday, March 12, 2024 - 10:00am to 12:00pm ET
Part 2: Wednesday, March 13, 2024 - 10:00am to 12:00pm ET

This was a joint webinar organized between IPEC-Americas and Generic Animal Drug Alliance (GADA).

During this two-part webinar, presenters representing GADA, IPEC-Americas and FDA - CVM (Center for Veterinary Medicine) provided an introduction to the regulatory process for animal drug development and approval, manufacturing, and regulatory policies, practices and ingredient requirements. CVM discussed considerations for excipients used in the animal drug industry, with a specific focus on generic animal drug products. Specifically,
> Excipient specifications and supplier CoAs;
> Use of flavoring agents;
> of co-processed excipients;
> Reference to Master Files;
> Considerations for excipients used in generic animal drug products (formulation review, novel excipients, etc.)

Learning/Awareness Objectives
Attendees were provided with:
> A general understanding of animal drug development and approval
> High-level comparison of animal drug vs human drug development
> FDA CVM policies, practices, and component recommendations for generic animal drugs
> Regulatory process as well as general chemistry, manufacturing, and control (CMC) requirements for animal drugs
> Considerations for the use of flavorings and co-processed excipients in animal drug.

Who should attend?
Human and animal drug:
> Excipient/ingredient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs

Note: Did you know this webinar may count toward continuing education credits? Check with your credentialing organization to confirm. A certificate of participation will be available for download upon completion of the webinar.