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FDA regulations make it harder to sue drug companies

BMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7554.1350-b (Published 08 June 2006) Cite this as: BMJ 2006;332:1350
  1. David Spurgeon
  1. Quebec

    The US Food and Drug Administration has added a preamble to its new regulations that will make it difficult for anyone to bring legal action against a drug manufacturer for harm caused by one of its products, says an article in this week's edition of the New England Journal of Medicine (2006; 354: 2409-11). The new regulations, which have attracted little publicity, come into effect on 30 June.

    Along with modest alterations to drug labelling to be phased in over the next …

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