Alexandria Pierce

Alexandria Pierce

Holland & Hart LLP

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AAFCO Updates to Model Regulations

2024 has ushered in the first major update in more than 40 years1 to the Association of American Feed Control Officials (AAFCO) Model Regulations for Pet Food and Specialty Pet Food. The new Model Regulations impose major...more

4/1/2024  /  Compliance , Food Labeling , Food Manufacturers , Pets , Regulatory Standards , Risk Mitigation

Alternative Means for FDA Approval of Pet Care Drugs – Part 3: Differences Between Major and Minor Species

This update is the final in a multi-part series exploring FDA approval of pet care drugs. In part one of our series we discussed that before an animal drug product can be legally marketed for use in animals, a New Animal Drug...more

8/22/2023  /  Animal Drugs , FDA Approval , Food and Drug Administration (FDA) , Orphan Drugs , Pets , Pharmaceutical Industry

Alternative Means for FDA Approval of Pet Care Drugs – Part 2: Extended Conditional Approval

In this article, we look at how Expanded Conditional FDA Approval has the potential to incentivize drug development and provide veterinarians with legally-marketed new animal drugs to treat serious or life-threatening...more

6/30/2023  /  Animal Health , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Healthcare , Pets , Prescription Drugs

Alternative Means for FDA Approval of Pet Care Drugs - Part 1: Conditional Approval

This update is the first in a multi-part series exploring FDA approval of pet care drugs. Before an animal drug product can be legally marketed for use in animals, a New Animal Drug Application (NADA) for the drug must...more

5/11/2023  /  CVM , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Pets , Prescription Drugs
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