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Baxter Corp.

Division of Baxter International Inc.

Latest From Baxter Corp.

FDA Tracks Critical Device Supply During Puerto Rico Hurricane Recovery

Continuing recovery efforts in Puerto Rico have US FDA focused on life-sustaining devices or those only made on the island. Meanwhile, manufacturers including Baxter, Zimmer, J&J and Abbott report varying impacts from the storms.

Medical Device Puerto Rico

CHMP Readies ‘Outstanding Issues’ Lists For Products Nearing EU Review End

Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.

Europe Approvals

FDA Clarifies Scope Of Its Emerging Technology Program

FDA has issued final guidance that clarifies the types of technologies eligible for acceptance into the agency's Emerging Technology Program. FDA also issues internal guidance to explain how reviewers should handle emerging technology applications.

Manufacturing Quality

Chinese Investor Consortium Buys SciClone But Relisting Possible

Against a background of positive changes to regulations and policies on pharmaceutical marketing in China, US-based SciClone has accepted a buyout offer from a consortium of Chinese investors, but may relist in China in the future.

China Commercial
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