The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information