Food, Drug and Medical Device Practice
Carter Ledyard & Milburn LLP has extensive experience addressing legal issues applicable to foods, drugs, and medical devices. For the past fifteen years, the firm has examined the regulatory issues faced by manufacturers and distributors of foods, food additives, nutritional or dietary supplements, drugs, biologic products, medical devices, and other biotechnology products. We have represented clients in the development of products from the initial application for an investigational drug or device exemption through pre-market approval, presentation to the appropriate advisory panel, and final approval.
By way of example, we have advised and assisted clients in filing:
- IDEs and IDE Supplements;
- PMAs and PMA Supplements and Amendments
- biologic product license applications;
- section 510-K pre-market notifications;
- establishment registration and device listings;
- US and Foreign drug master file/ product master file (DMF/PMF) submissions;
- food additive and GRAS petitions; and
- comments in administrative rulemakings.
We stride to maintain a positive and effective relationship with the FDA, working with the Agency to obtain preliminary advice, maintain ongoing project communication, and find efficient pathways to successful outcomes. We also collaborate frequently with the FDA in order to guide our clients on internal matters, heading off potential regulatory issues up front.
During the course of such representation, the firm's attorneys have been deeply involved in virtually all aspects of product development, including:
- protocol, registry and consent form development;
- compliance advice to clinical study monitors;
- preparation of annual, final, and unanticipated adverse reaction reports;
- preparation for GMP inspections and clinical study data audits;
- organization and presentation of data in pre-market approval applications;
- labeling;
- and insurance reimbursement.
In addition, we have assisted in the acquisition and disposition of companies in these industries and have drafted agreements with clinical investigators, material and component suppliers, licensees, consultants, and distributors. We have also represented drug manufacturers and their lenders/underwriters in connection with investments in such companies, including the issuance of securities.
The firm is also invested in helping foreign companies bring their medical devices and drugs into the U.S. market, for the benefit of all. We can help guide such companies through the administrative labyrinth to gain FDA approval for their products.
During the past year, this practice group has continued to be extremely active, and we have undertaken the following tasks, among others:
- Representing publicly-traded biopharmaceutical company that acquires, develops, and commercializes innovative products to advance cancer care.
- Representing manufacturer of dietary supplements in FDA reviews and approvals.
- Representing a leading global financial services firm in connection with lending to a publicly-traded biopharmaceutical company.