Food and Drug
The regulatory practice at Powers Pyles Sutter & Verville is backed by substantial experience representing clients in matters involving the Food and Drug Administration.
Our attorneys have experience guiding companies through the FDA’s premarket clearance process and assisting with product development and commercialization strategies to minimize FDA regulatory costs. Powers attorneys also have experience in providing advice on FDA labeling, advertising, and manufacturing requirements, as well as advice and guidance on other issues arising during the progression of a product from premarket clinical testing to postmarket commercial distribution.
We assist clients with issues relating to medical devices, biologics, food, food additives, dietary supplements, nutritional products, cosmetics products, and veterinary products. Most of Powers’ FDA product approval work has involved medical devices. Our attorneys have successfully prepared dozens of premarket notification submissions or “510(k)s” on behalf of clients. We have successfully brought to market specialized wheelchairs, circulatory assist devices, cranial headbands, an allergy control device, and teleradiology products. Our medical device practice also includes assistance on matters involving premarket approval, investigational device exemptions, institutional review boards, humanitarian devices, medical device reporting, and the FDA’s quality system regulations.
A key element of our representation includes responding to and overcoming roadblocks and obstacles in the regulatory arena. If problems arise that involve concerns of a broader public policy nature, we elevate the issues within the FDA as appropriate, to the office of the relevant Center Director, the Office of the Commissioner and/or the Office of the General Counsel. We may also direct our efforts outside of the FDA by targeting the U.S. Department of Health and Human Services, the White House and/or Congress.
Another focus area includes representing clients on FDA enforcement and compliance matters. Among the members of the firm’s litigation group is a former supervisory Assistant U.S. Attorney with substantial experience with FDA-related litigation.
Our attorneys have undertaken compliance projects in numerous situations, including:
- Helping a manufacturer of over-the-counter drugs with a product recall
- Reviewing and revising draft labeling for dietary supplements
- Assisting manufacturers in responding to adverse inspects (483s) and warning letters
- Representing a device manufacturer during a seizure action
- Defending employees of a vaccine manufacturer against criminal charges of falsifying data and knowingly violating good manufacturer practices and drug export requirements