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China Addresses Life Sciences Regulatory Compliance Concerns

China has often faced criticism for lax regulation of drug and medical device manufacturing. In addition, long-term accusations of bribery for inspection favoritism is still a real concern.  Do [...]

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FDA Warning Letters Emphasize Document Control System Compliance

First quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples.  Both [...]

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FDA States Clear cGMP Expectations for Combination Products

The Food and Drug Administration (FDA) recently released a final guidance on Current Good Manufacturing Practice (cGMP) Requirements for Combination Products. This guidance provides clarification [...]

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