Why This Course is Important
Without this training, sponsors and manufacturers risk regulatory missteps, product misbranding, or costly enforcement actions that could impact market access and business reputation.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address.
Key regulatory references include:
- 21 CFR Part 510 – New Animal Drugs
- 21 CFR Part 516 – New Animal Drugs for Minor Use and Minor Species
- 21 CFR Part 520 – Oral Dosage Form New Animal Drugs
- 21 CFR Part 522 – Implantation or Injectable Dosage Form New Animal Drugs
- 21 CFR Part 524 – Ophthalmic and Topical Dosage Form New Animal Drugs
Course SKU
FR-26-1867-1