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
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.