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Baxter Healthcare Corp.

Division of Baxter International Inc.
www.baxter.com

Latest From Baxter Healthcare Corp.

FDA Warns Lymol To Assess Talc Lead Risk Per ICH Q3D; Puts Others On Notice

A warning letter to firm with legacy talc drug product puts pharmaceutical industry on notice: the US FDA expects applicants to meet requirements agency imposes post-approval for matters like elemental impurities compliance.

Enforcement Quality

China Shows More Of An Open Door To Overseas Medtech Industry

China's influence on global medtech regulation and the country's continuing emergence on the world stage will be felt increasingly in the coming years. But while China may be less inclined to exclude big medtech multinationals, it feels no compulsion to harmonize totally with the US and/or EU systems.

China Regulation

With New Initiatives, Case For Quality Embarks On Mission To Create 'Safe Space,' Engage CEOs, #makeCAPAcool

Quality and regulatory officials from Medtronic, Hologic, Baxter Healthcare and Boston Scientific – among others – are working with the joint US FDA/MDIC Case for Quality to fully realize a two-year strategic plan that targets corrective and preventive action (CAPA), CEO engagement in quality activities, career paths in device quality, and more.

Quality Control Manufacturing

The Quality Lowdown: ICH Q13 and Q14, Gene Therapy CMC, Drug Shortage Gaps, And An Excipient Misstep

ICH launches continuous manufacturing and analytical procedure guidelines while US FDA promises advice on gene therapy CMC, battles drug shortages and sees what went wrong with certain eye injections.

Quality Manufacturing
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