Letters FDA letters and sponsor announcements

From the FDA, we still hear mostly thunderous silence

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h3763 (Published 14 July 2015) Cite this as: BMJ 2015;351:h3763
  1. Erick H Turner, physician-researcher1
  1. 1Oregon Health and Science University, Portland, OR 97239, USA
  1. turnere{at}ohsu.edu

Lurie and colleagues’ comparison of FDA letters not approving applications for new drugs and associated public announcements from sponsors provides a valuable but rare peek behind the Food and Drug Administration’s “iron curtain.” The discussion section begins, “our analysis found that the FDA’s reasons for not approving marketing applications for new molecular entities are not being fully conveyed to the public.”1 On the basis of the …

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