Laws, Regulations, Guidance, and Concept Papers

A slow week for guidance publication:  2 from FDA and 1 from WHO. The non-guidance area saw the usual collection from EMA, MHRA, FDA and 1 each from MHRA and TGA.

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Enforcement included:

  • 2 warning letters to drug manufacturers
  • 2 warning letters to compounding pharmacies
  • FDA released 2 form 483s issued to sites in India

We see the usual collection of drug recalls and import alerts. For auditors, Rx-360 just published an Audit Manual for Data Integrity. It is free to all, membership in the organization is not required.