Democratic Congress could mean FDA rule over biotech generics

11/21/2006 | Wall Street Journal, The · Reuters

The change in control of Congress could mean Democrats will introduce legislation to give FDA the authority to approve follow-on biologics. Biotech companies say their products are too complicated to recreate, generics would need clinical trials to ensure the safety and efficacy of their copycat products, and a push for generics could impede R&D efforts.

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Wall Street Journal, The · Reuters

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