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FDA Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

Document Type:
FDA Guidance for Industry
This guideline provides sponsors with guidance on the types of toxicity information the FDA recommends to be provided to the FDA to support the use of new Excipients as components of drug products

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