We use cookies to improve security, personalize the user experience,
enhance our marketing activities (including cooperating with our marketing partners) and for other
business use.
Click "here" to read our Cookie Policy.
By clicking "Accept" you agree to the use of cookies. Read less
Understanding the Animal Drug User Fee Act of 2003 [ADUFA] and Its Significance
Definition & Meaning
The Animal Drug User Fee Act of 2003 (ADUFA) is a federal law in the United States that allows the Food and Drug Administration (FDA) to collect fees related to the approval of animal drug applications. This act was signed into law by President George Bush and modifies the Federal Food, Drug, and Cosmetic Act (FFDCA). The purpose of ADUFA is to provide the FDA with additional resources to expedite the review process for new animal drugs, ensuring they are safe and effective for both animals and humans, particularly in cases where the animals are intended for food consumption.
Table of content
Legal Use & context
ADUFA is relevant in the legal context of animal health and safety, particularly in the regulation of veterinary drugs. It applies to various legal areas, including administrative law and regulatory compliance. Users may encounter this act when dealing with animal drug applications or when seeking to understand the FDA's regulatory framework. Legal forms related to animal drug applications can be managed using templates available through US Legal Forms, which are drafted by qualified attorneys.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
For instance, a pharmaceutical company may submit a New Animal Drug Application (NADA) for a new medication intended for livestock. Under ADUFA, the company would pay a fee to the FDA, which would then use those funds to expedite the review process. This ensures that safe and effective treatments are available to veterinarians and farmers more quickly.
Relevant laws & statutes
The primary statute related to this term is the Animal Drug User Fee Act of 2003 itself. It is an amendment to the Federal Food, Drug, and Cosmetic Act, which governs the regulation of food and drugs in the U.S. Other related laws may include subsequent amendments or reauthorizations of ADUFA.
Comparison with related terms
Term
Description
Key Differences
Prescription Drug User Fee Act (PDUFA)
A law that allows the FDA to collect fees for human drug applications.
PDUFA focuses on human drugs, while ADUFA focuses on animal drugs.
Federal Food, Drug, and Cosmetic Act (FFDCA)
The overarching law that governs the regulation of food and drugs in the U.S.
ADUFA is a specific amendment to FFDCA focusing on animal drugs.
Common misunderstandings
What to do if this term applies to you
If you are involved in the development or approval of an animal drug, familiarize yourself with ADUFA and the associated fees. Consider using US Legal Forms for templates related to animal drug applications, which can simplify the process. If your situation is complex, consulting with a legal professional may be beneficial to ensure compliance with all regulations.
Find the legal form that fits your case
Browse our library of 85,000+ state-specific legal templates.