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: Format and Content for the CMC Section of an Annual Report, 1994


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

Document Type:
FDA guidance for industry
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.

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