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Homeopathic Divide: FDA Talks Pre-Market Approval As Industry Floats Label Changes

 
• By Malcolm Spicer

FDA officials point out label changes would not resolve their concerns that homeopathics, unlike other Rx and OTC drug categories, are available without pre-market approval. Stakeholders emphasize the products’ safety while suggesting changes such as more information on labels to better identify ingredients.

Homeopathic industry stakeholders’ concessions on potential label changes or other relatively small adjustments to FDA’s regulation of their products might not be enough to convince the agency to continue giving the category a pass on pre-market approval.

Representatives of manufacturers, research and professional organizations and trade groups speaking at an April 20-21 public hearing for comment on...

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