ANDA Counseling

Farney PC attorneys regularly assist clients in all aspects of the complex ANDA process, which allows drug manufacturers to bring generic products to market while limiting the expense and delays associated with clinical trials. Our comprehensive approach to ANDAs may include product and manufacturer selection, formulation and design, the preparation of Paragraph IV letters, the assessment of potential litigation, and licensing and marketing strategies. Our extensive experience and understanding of the regulatory environment is critical in determining each client’s strategic approach to an ANDA filing, based on up-front discussions and decisions on overall objectives, risk tolerance and financial standing. We then provide guidance through each step in advance of the application filing, as well as post-filing legal challenges and regulatory hearings.