Monday, August 25, 2008

FDA to Revise Rules For Cold Medications Meant for Children

From the Washington Post:
The Food and Drug Administration yesterday announced plans to revise standards for over-the-counter cough and cold medications for children, a step that could lead to removing the popular products from the market.

In response to rising concerns that the products are ineffective and could be unsafe, the agency said that, for the first time in decades, it will revamp the criteria that have allowed the products to remain on drugstore shelves.

"Modern science has advanced since, and this is an opportunity to apply modern science to evaluate these products," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

As the first step in that process, the agency will hold a special hearing Oct. 2 to begin to consider a series of questions, including: What types of studies should be done to evaluate the products? Should the products remain available without a prescription? How should the doses be determined? Should products that combine different ingredients remain available? ...more

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