Article

Niksch selected as industry representative on FDA panel

Irvine, CA-Barbara A. Niksch, MBA, has accepted an appointment from the U.S. Department of Health and Human Services to serve as industry representative on the FDA's Ophthalmic Devices Panel of the Medical Devices Advisory Committee. Niksch is vice president of regulatory, quality, and clinical affairs, Visiogen Inc.

Selected by a committee of her peers in the medical device industry for her experience and leadership, Niksch will contribute to the panel by providing balanced recommendations based on her industry knowledge. As an industry representative, she will act on behalf of regulated industry at committee meetings. Niksch will present issues from the perspective of the affected industry and not as an individual from a specific sponsor.

The panel consists of seven voting members with specific expertise in ophthalmology and two non-voting members (the industry representative and the consumer representative).

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