Lack of investment in regulatory science is part of “innovation gap,” believes FDA commissioner

BMJ 2011; 343 doi: (Published 08 December 2011) Cite this as: BMJ 2011;343:d8017
  1. Elizabeth Sukkar
  1. 1London

Margaret Hamburg, the commissioner of the US Food and Drug Administration, believes that a failure to invest “adequately” in regulatory science has been one of the reasons why fewer new drugs have been making it to the market.

She told a drug and biotechnology industry conference organised by the Financial Times and held in London on 5-6 December that regulatory science was the “bridge” between a “good idea” and getting a new product to the public. The FDA defines regulatory science as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of products.

Better regulatory science could make it easier to determine when a drug may fail, she said. She added that the FDA had developed centres of …

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