Woodcock doubtful of proposed FDA foreign inspection rules

05/1/2008 | Wall Street Journal, The

FDA drug unit director Janet Woodcock on Thursday rejected calls by Democratic lawmakers to back legislation that would tighten rules on product imports, expressing concern with parts of the bill that would require the agency to inspect overseas manufacturers every two years. Woodcock, who said the inspection requirement might be a financial burden to the FDA, was also reluctant to impose registration user fees for drug and device makers.

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