Regulatory News In Brief

CDRH director's plea to industry: Device center director Dan Schultz urges companies submitting complementary applications to CDRH to "get together and share information between themselves" in order to facilitate the review process. During a recent Food & Drug Law Institute meeting, he recalled FDA's review of Amplichip, which consisted of separate applications submitted by Roche and Affymetrix. Schultz noted: "One of the things that made this a little bit challenging for us was that those two companies really weren't talking to each other very much and we had to review the two separate applications essentially separately and sort of put them together ourselves and try to make sure that we had them cleared at roughly the same time." He added: "Recognizing that we are going to be seeing more and more of these products come in as combinations or as products that are being used together, the extent that industry can get together and share information between themselves...and share it with us, would really make our lives a lot easier"...

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