Food and Drug Administration Group

Bringing a new drug or medical device to market is a challenging, expensive and time consuming undertaking. A complex array of regulations makes the task even more daunting. The U.S. Food and Drug Administration is charged with the responsibility of assuring that drugs and devices are safe and effective. Regulations developed by the FDA govern nearly every aspect of the design, development, manufacture and marketing of these products.

Important questions must be answered. How is the product classified? Is clinical testing necessary? What performance claims can be made, when and by whom? What happens when a product fails to perform as expected or when a patient is injured? When is a company subject to being inspected by the FDA? What can happen if an inspection reveals a problem? Failure to understand and comply with FDA regulations can result in delay, unanticipated costs or enforcement actions than can wreak havoc on the company. Timely and accurate guidance can help executive management understand and reduce risk. Good legal counsel can help regulatory and quality assurance staffs make informed decisions with confidence. And, when necessary, an experienced legal advisor can help address a problem with the FDA before it becomes a crisis.

At Bose McKinney & Evans, we understand the FDA terrain. From questions about compliance with FDA quality system regulations and good manufacturing practices to issues involving Institutional Review Board approvals of clinical studies and protection of patients’ rights, our Health Law Group can help you solve the thorniest problems. Our goal is to help drug and device manufacturers manage risk and avoid the pitfalls that otherwise might keep new medicines and technologies from reaching the marketplace.

In addition, our Health Law Group works closely with attorneys from the firm’s Business Services, Intellectual Property and Litigation Groups to ensure that clients have the right advice at the right time. Bose McKinney & Evans has the experience to address issues across a broad spectrum. For example, growing companies may need assistance with corporate structure, financing and employee benefit plans. Developing new products or entering new markets requires careful planning to obtain the maximum protection for the company’s intellectual property under applicable patent, copyright and trade secret laws. And, should the unthinkable happen, the firm’s ability to represent clients in court or before administrative agencies is readily available. In short, we seamlessly deliver a full range of legal services needed by medical device and pharmaceutical manufacturers so our clients can stay focused on business objectives.

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