Food, Drug, Device, Biologic, & Cosmetic

Our Food and Drug team provides daily counseling on a wide variety of regulatory issues. AGG is unique in that it can provide a number of services to our pharmaceutical and biotechnology clients beyond merely the FDA-related work. Therefore, rather than list representative “experiences” that any reputable food and drug practice can provide, which we do daily, the following is merely some recent examples where our Food and Drug team and other AGG practice groups assisted our clients.

• Serve on a dozen Promotional Review Committees for companies with either FDA-approved products or products in the investigational stage; we serve as the legal representative to ensure compliance with FDA requirements, but lawyers in our Healthcare, Data Privacy, and Trademark practices often assist, as needed.
• Draft a number of agreements, such as Product Development and Collaboration, Manufacturing and Supply, Distribution, Intellectual Property License, Website Development, Website Terms and Conditions, and E-commerce for a contract manufacturer of over-the-counter pharmaceutical and dietary supplement products. AGG’s Food and Drug and Corporate practices jointly counsel this client.
• Represented PL Developments in its acquisition of Teva Pharmaceuticals’ U.S. over-the-counter drug store-brand portfolio and a manufacturing facility. The deal involved lawyers from AGG’s Food and Drug, Corporate, and Tax practices.
• Provided regulatory assistance to HealthEdge Investment Partners in its acquisition of WraSer Pharmaceuticals and Xspire Pharma to consolidate into a new company. Members of AGG’s Food and Drug and Healthcare practices assisted in the transaction.
• Served as regulatory counsel to Sebela Pharmaceuticals in its acquisition of Braintree Laboratories, a leader in the gastroenterology pharmaceutical market. Members of AGG’s Food and Drug and Healthcare practices assisted in the transaction.
• Advised in the formulation of a strategic alliance between a large pharmaceutical company and our client, an emerging drug company, to develop license and market a generic product for the treatment of pediatric epilepsy. AGG’s Food and Drug and Corporate practices were involved in this project.