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Warning Letter Close-Outs – March 2015

Four FDA close-out letters were released in March.

Medical Device Regulation

Recent Warning Letter Close-Outs

Five FDA close-out letters were released from Feb. 18 through March 31.

Medical Device Regulation

Warning Letter Roundup & Recap

Karl Storz didn't have design validation data to show that a brush specified in the instruction manual for its Flex-X2 ureteroscope was appropriate for cleaning the device; QS and MDR reg violations identified at maker of coronary bypass cannulas. Six quality-related warning letters were listed by FDA from Dec. 18 through Jan. 14.

Medical Device Regulation

Deals Shaping the Medical Industry (03/08)

The dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents. All transactions are excerpted from Windhover's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.

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