In mid-February, FDA Commissioner Margaret Hamburg traveled to India to meet with government officials on quality and other regulatory topics. This visit included the signing of a “Statement of Intention” to clarify the points on which both countries will cooperate, such as: ● sharing of CGMP compliance and facility information, ● India observing FDA inspections, and ● enhancing communication and public meeting collaboration. [Hamburg’s Feb. 14 and Feb. 21 blogs on the trip. See IPQ Aug 22 for an analysis of FDAs inspection findings of data integrity problems in India.]
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