Bryan Cave attorneys counsel companies and investors concerning the probable FDA regulatory status and approval pathway of proposed new products and concepts. Specific areas in which we regularly assist our clients include:

• Determining the application type and regulatory pathway, and assisting with supporting data required for approval
• Drafting meeting requests and preparing for meetings with FDA and expert committees, as well as counterparts in key international markets, including the European Union
• Assisting with the preparation of requests for determinations for combination products
• Resolving complications that may arise during FDA application review
• Providing guidance throughout the approval process
• Analyzing the nature of applications and the applicability of FDA "exclusivity" and patent provisions
• Advising clients on life cycle management issues
• Reviewing promotional statements and claims to promote products in the market
• Respond to proposed rulemaking by key federal and state agencies
• Represent clients before the US Department of Agriculture regarding issues including meat and poultry inspection and safety, biotechnology and school lunch and other USDA administered programs

A Closer Look at how we can help:

Product Development
We represent clients before the FDA, USDA, and the U.S. Patent and Trademark Office (USPTO) in all phases of the product development cycle. We provide guidance on product and ingredient notifications, bioresearch and FDA inspections, regulatory and due diligence audits, and Good Manufacturing Practice and Quality Systems Regulation requirements. Our attorneys also advise on licensing agreements, manufacturer and distributor registration, pending legislation, product corrective actions, and regulatory aspects of product development.

Food Safety
Nothing is more important to a food company than its reputation for distributing safe products. Yet food safety issues continue to pose new and difficult challenges, including consumer allergies, gaining approval for new food ingredients and food contact substances, differing national standards on safety, and new legal and regulatory perspectives on existing ingredients. Our attorneys have helped clients facing all of these issues, serving as counselors, advocates, and advisors in state, federal, and international forums.

Labeling, Packaging, and Recalls
Our team reviews labeling and packaging to ensure compliance with state and federal regulations, and assists clients in addressing food-labeling issues. We advise manufacturers, distributors, and retailers when a recall is required. We assist clients with all stages of the recall process from notifying regulators to public relations. In addition to crafting legal notices, working with regulatory agencies and insurance carriers, distributors, and customers, our attorneys and public relations personnel help clients develop and implement a media relations plan.

Brand Name Identification and Protection
Trademark and copyright practitioners help clients to protect brand value. Our lawyers work with clients to develop a strategic approach to the acquisition, maintenance and defense of rights, including trademarks, copyrights, patents, trade secrets, and other types of intellectual property. We file and prosecute applications to acquire trademark and copyright registrations and issued patents before the U.S. Copyright Office and the USPTO. We enforce and defend intellectual property rights and infringement claims in state and federal courts and with U.S. Customs and Border Protection (CBP) and other federal enforcement agencies. We also coordinate these protection and enforcement activities on a worldwide basis.

Promotion, Advertising, Web, and E-Commerce Issues
In the important area of communications, we advise on FTC and FDA product advertising and promotion requirements, including endorser liability, advertising substantiation, false and deceptive advertising, and First Amendment protection. Doing business on the Web requires specific legal counsel on matters such as Web site development agreements, search engine agreements, trademarks and co-branding, data privacy, and security. Our team has developed best practices for addressing e-commerce legal issues facing the food industry.

Litigation and Dispute Resolution
When our clients face legal disputes, we focus first and foremost on protecting their business interests. With litigators who think like businesspeople, we devise optimal strategies for efficient, favorable results. With one of the largest, most comprehensive litigation practices in the United States, we provide a full range of dispute resolution and litigation services.

Distribution and Franchise
Our attorneys have decades of experience guiding businesses in all phases of the distribution relationship. We are well-versed in identifying and solving the complicated legal questions involved in structuring and financing distribution channels; renewing, revising and expanding existing distribution channels; and in the acquisition, syndication, sale, and termination of channel members. Our team also negotiates and resolves disputes between suppliers, resellers, brokers, dealers, distributors, and franchisees, and has handled litigation and arbitrations throughout the country.

Imports/Exports
Our attorneys prepare and review international sales agreements, foreign source production agreements, and agent and distributor agreements. We advise on U.S. export control and anti-boycott laws, international competition policy, export finance, international payment procedures, foreign exchange matters, global customs laws and procedures, and international transportation. Our team also provides advice concerning classification and valuation of imports as well as entry procedures. Our attorneys provide representation before the CBP and the U.S. Court of International Trade. We also represent clients in U.S. International Trade Commission (ITC) proceedings under antidumping and countervailing duty laws, and related measures for redressing unfair trade practices or providing assistance to U.S. industries injured by imports.

Routine and Special Inspections
Our team helps clients undergoing routine or special inspections. Having counseled scores of businesses through this process, we are familiar with the best practices and can help clients navigate the complicated legal and regulatory waters.

Enforcement Proceedings
Due to the extreme sensitivity surrounding issues of FDA-related allegations, it is critical for clients to work with business counsel who are rooted in real-world experience. Bryan Cave offers the complete range of legal advice, from the establishment and maintenance of compliance programs to representation before U.S. Attorneys' Offices, the United States Department of Justice, and FDA enforcement proceedings. We represent clients in matters ranging from warning letters to defending companies and individuals facing criminal prosecution.

Product Liability/Defense of Contaminated Food Claims
Contaminated food claims have legal, operational, and public relations consequences. We guide clients through all facets of these challenges, including dealing with regulatory authorities, the media, and customers, and in defending product liability actions.

Additionally, our strategic communications practitioners are nationally recognized for developing strategy, crafting messages, and for designing campaigns that help clients meet clearly defined objectives.

Medical Devices
Dramatic advances in medical technology have made the medical device industry one of the fastest growing business sectors today. But a rapidly changing legislative and regulatory landscape, coupled with increasing civil and criminal liability, has posed significant challenges for medical device manufacturers.

Bryan Cave is uniquely positioned to help you meet these challenges, with a team of attorneys having extensive experience counseling manufacturers of medical devices and equipment. Our Medical Device attorneys provide fully integrated experience in regulatory issues, intellectual property (IP) law, business law, and legislative affairs, enabling us to craft effective strategies for medical device manufacturers.

We understand that navigating the complicated and ever-changing maze of regulatory issues can be one of the biggest obstacles to bringing a medical device to market. At Bryan Cave, we employ a multidisciplinary approach to helping medical device manufacturers manage the regulatory process, including food and drug regulations, Medicare and Medicaid coverage rules, and compliance with health care fraud and abuse laws such as the Anti-Kickback Statute and the Stark Law.

Bryan Cave attorneys have extensive experience counseling companies before the U.S. Food and Drug Administration (FDA) and its counterpart authorities abroad in all phases of the product development cycle, including pre-clinical activities, clinical trials, the application process, and the post-market environment. We have been intricately involved in representing sponsors, public and private institutions, institutional review boards (IRBs), clinical research organizations (CROs), site management organizations (SMOs), and principal investigators on a variety of complex matters involved in clinical research.

Specific areas where we regularly assist our clients include:

• Advising on device clearance and approval strategies, including 510(k) strategies, product classification, and reclassification
• Counseling on investigational device exemption (IDE) requirements, clinical trial issues, and humanitarian device requirements
• Developing regulatory strategies such as fast track, accelerated approval, and treatment IDEs to bring new products to market and to patients as quickly as possible
• Providing counsel throughout the application process, including leading FDA meetings and appeal