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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.
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| Submitting Samples and Analytical Data for Methods Validation |
| Internet: | http://www.fda.gov/cder/guidance/ameth.htm |
| Origin/Publisher: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/cder/guidance |
| Content: | This guideline describes the procedure within the framework of registrations, both for NDA´s and ANDA´s, as to how FDA checks the validation of analytical methods, if necessary also with its own analyses in FDA laboratories |
| Document Type: | FDA guide to inspection |
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