Kleinfeld, Kaplan & Becker advises on legal and regulatory issues associated with animal food and drugs – including prescription and over-the counter (OTC) drugs, as well as “dietary supplement”-type products and veterinary biologics regulated by USDA.
Our firm provides advice on all aspects of animal feed and drugs, including:
- Investigational New Animal Drug Applications (INADs)
- New animal drug applications (NADA), abbreviated NADAs (ANADA), and conditional approval (CNADA)
- Veterinary biologics establishment and biological products licenses
- Medicated feed
- Animal food formulation and labeling
- Pet food formulation and labeling
Animal drug current good manufacturing practices (cGMP)
- Animal food preventive controls and cGMP regulations
- Establishment registration and product listing
- User fees
- FDA reporting requirements
Safety, Recalls and Reporting
Our firm helps clients assess the risks posed by safety-related manufacturing deviations and contamination, determine whether a recall is needed, and what the scope of any recall should be. We advise on reporting, recall implementation and effectiveness checks, documentation of corrective and preventive actions, and governmental inspections relating to product deviations and recalls.
Labeling and Advertising
Our firm advises on all areas of animal drug, medicated feed and animal food labeling, including wording, formatting, submission and/or approval of labels, advertising and other promotional materials (including social media and web promotion).
Our firm represents clients in enforcement actions, including responses to FDA inspectional observations, warning letters, recall requests and import detentions, as well as more significant actions such as seizures and injunctions, and negotiation of consent decrees.
Contracts and Due Diligence
Our firm supports clients in negotiating and drafting regulatory-related agreements such as guarantees, labeling agreements, supply agreements, quality agreements, etc. We also carry out due diligence analyses of drug and biologic companies and products that are being considered for acquisition or investment.