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FDA seeks leaders for product innovation, safety group

By Lorraine Heller, 08-Oct-2007

Related topics: Regulation, Food safety and labeling

The US Food and Drug Administration (FDA) is calling for nominees to serve on the board of a new non-profit organization designed to enhance the development and safety of food and food ingredients.

FDA's Reagan-Udall Foundation will also aim to modernize product development and accelerate innovation in the medical, veterinary and cosmetics fields.

 

 

 

The non-profit group was founded on September 27, when the President signed into law the agency's Amendments Act of 2007 (FDAAA). FDA is now looking to create the foundation's board of directors, and is calling for nominations of candidates from trade organizations, advocacy groups and scientific societies.

 

 

 

According to FDA, the duties of the foundation will include the identification of unmet needs in the development, manufacture, and evaluation (including postmarket evaluation) of the safety and effectiveness of FDA-regulated products, and the establishment of scientific and other projects and programs to meet those needs.

 

 

 

The board of directors will oversee the organization's activities, approve programs and monitor their effectiveness, coordinate the groups' activities with federal research programs, award grants, and raise resources.

 

 

 

The 14-member board will be composed of: four representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries; three representatives of academic research organizations; two representatives of patient or consumer advocacy organizations; one representative of health care providers; and four at-large representatives with expertise or experience relevant to the purpose of the foundation.

 

 

 

"The Board must include individuals with expertise in areas including the sciences of developing, manufacturing, and evaluating the safety and effectiveness of devices, including diagnostics, biological products, and drugs, and the safety of food, food ingredients, and cosmetics," wrote FDA in a Federal Register notice published on October 3, 2007.

 

 

 

The initial board will be appointed by October 27 by the ex officio board members designated in the statute: The Commissioner of Food and Drugs, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Director of the Agency for Healthcare Research and Quality.

 

 

 

Nine Board members are to be appointed from a list of candidates provided by the National Academy of Sciences. Five Board members are to be appointed from lists of candidates provided by patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations.

 

 

 

Nominations must be received by October 15, 2007.

 

 

 

To access the Federal Register Notice, click here .