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On August 8, 2009, Emord & Associates, PC, filed suit in the US District Court for the District of Columbia against the Food and Drug Administration on behalf of the Alliance for Natural Health US, dietary supplement formulators Durk Pearson and Sandy Shaw, and the Coalition to End FDA and FTC Censorship. Currently, FDA is focusing a lot of its efforts on AERs, having recently released two guidance documents--one for dietary supplements and another for monographed OTC drug products. The FDA team found that documentation of deviation reports was inaccurate in some instances. |
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