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US FDA Moves Homeopathic Drug Enforcement To Risk-Based Approach

 
• By Malcolm Spicer

Products with routes of administration other than oral and topical or intended to be used for the prevention or treatment of serious or life-threatening diseases and conditions will be among those prioritized for enforcement and "regulatory actions," draft guidance notes.

The US FDA will put more teeth into its homeopathic drug industry oversight under a draft guidance that identifies problems it will target for enforcement while allowing the products to remain available without pre-market approval.

The draft guidance published Dec. 18 also does not specify testing of homeopathic ingredients for certain indications but states that FDA will use an enforcement approach similar to its...

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