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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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| FDAMA Section 116 Implementation Information |
| Internet: | http://www.fda.gov/cder/guidance/fdama116.pdf |
| Origin/Publisher: | Center for Drug Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; |
| Content: | Information on section 116 of FDAMA amending the Food, Drug, and Cosmetic Act by adding section 506A which provides requirements for making and reporting manufacturing changes to an approved application |
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