Drug Products Labeled as Homeopathic

7 December 2022 – the FDA published final guidance on homeopathic drug products for FDA staff and industry.

This guidance describes how FDA intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval. FDA has developed a risk-based approach under which the Agency intends to prioritize enforcement and regulatory actions involving certain categories of such products that potentially pose a higher risk to public health.

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