Kelley Drye's team of Food and Drug lawyers strives to integrate our clients' business strategies
with Food and Drug Administration (FDA) compliance and to help resolve regulatory enforcement matters when they arise.
Our clients range from large companies to small enterprises and include national advertisers, direct marketers,
manufacturers, importers and distributors. They develop and market a broad spectrum of FDA-regulated products,
including food, cosmetics, dietary supplements, over-the-counter drugs, and medical devices. Working side-by-side
with business development and marketing professionals, we assist in developing products, labels, and promotional
materials that achieve our clients' goals without running afoul of regulatory requirements. Our goal is always to
help our clients avoid costly setbacks associated with regulatory enforcement by minimizing their risk at the outset.
We have successfully represented clients in connection with enforcement matters including warning letters, inspections,
product seizures, and import detentions; and we regularly assist clients in conducting product recalls, whether
self-initiated or performed at the request of the FDA. Together, our professionals have the knowledge and experience
to provide a broad range of regulatory counseling services that include representation before FDA, Federal Trade
Commission (FTC), and the related federal and state agencies.
Because the firm maintains a significant practice representing direct marketers and electronic retailers that market
their products through broadcast, print or online media, our lawyers are keenly aware of the regulatory challenges
posed by overlapping FDA and FTC jurisdiction. With close knowledge of the FDA's enforcement priorities and in
depth experience with the FTC's regulation of advertising, our team can provide comprehensive legal advice with an
eye towards giving clients a competitive edge.
Our scope of work for our Food and Drug clients includes:
- Regulatory counseling including the FDA, FTC, and related federal and state agencies
- Resolving enforcement actions through negotiation with the FDA
- Assisting manufacturers and importers with 510(k) pre-market notifications for medical devices
- Assisting food, drug, and device companies with the processes of registering with the FDA and, if needed, listing their products
- Preparing 75 day new dietary ingredient (NDI) notifications for dietary supplement ingredients
- Handling due diligence for commercial transactions and financings
- Preparing comments on proposed rulemakings
For further information about Kelley Drye's Food and Drug Law Practice Group, please contact:
Lewis Rose
(202) 342-8821
lrose@kelleydrye.com
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