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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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| PAC-ATLS: Post approval Changes - Analytical Testing Laboratory Sites, April 1998 |
| Internet: | http://www.fda.gov/cder/guidance/2043fnl.pdf |
| 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 FDA guideline regulates under what conditions the change made to an analytical laboratory is possible and in what form the FDA must be informed. |
| Document Type: | FDA Guidance |
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