Blog Home TAG: 21 CFR Part 4

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 [...]


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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