New FDA Fecal Transplant Guidance Should Ease Ferring’s Path To Commercialization

 
• By Sarah Karlin-Smith

Final guidance excludes stool banks, putting in place more limited enforcement discretion regarding the requirement of an investigational new drug application for use of fecal transplants to treat C. diff infections, likely paving way for shift to any FDA-approved product.

open path with sunrise
FDA finalized a draft guidance on unapporved fecal transplants for C. diff infections ahead of likely first product approval. • Source: Shutterstock

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