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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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| Format and Content for the CMC Section of an Annual Report, 1994 |
| Internet: | http://www.fda.gov/cder/guidance/cmc1.pdf |
| Origin/Publisher: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA |
| Content: | These FDA guidelines described what information CDER expects in the Annual Report for NDA´s, ANDA´s and AADA´s. This also includes the information on ongoing stability tests. |
| Document Type: | FDA guidance for industry |
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