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: PAC-ATLS: Post approval Changes - Analytical Testing Laboratory Sites, April 1998
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 , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070582.pdf
Document Type:
FDA 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.
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