Our collection of FDA Guidance Documents is organized by year. Clicking on a link in the table immediately below will take you to the list for the year indicated. The table is arranged from most recent documents (at the top) to oldest documents. The much larger tables that contain descriptions and links to copies of the documents themselves start with the current year and work backwards to make browsing the lists easier. New FDA guidance documents can be found at http://www.fda.gov/cber/whatsnew.htm.

The "All Available Guidance Documents" page contains all available guidance documents archived by BCG. Use this page to search for a particular type of guidance document using a key word.

Clicking of the "Get it" link will display the indicated document. To save a copy of the document for yourself, click on the link with your right mouse button (Windows, OS/2, Linux, and Solaris) or click and hold the single mouse button (Mac) to display the context menu. Select "Save Link As...", select the appropriate location (folder) and press "Save."

Date Issued	Title	Pages	Document (.pdf)
4/12/79	Guideline for Interpretation of Potency Test Results for All Forms of Adsorbed Diphtheria and Tetanus Toxoids (Federal Register Document) (FDA197904Afr)	1

1978
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Date Issued	Title	Pages	Document (.pdf)
3/30/78	Package Insert:  Immune Serum Globulin (Human) FDA197803A	7
1978	General Considerations for the Clinical Evaluation of Drugs (FDA197800A)	13

1977
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Date Issued	Title	Pages	Document (.pdf)
1977	General Considerations for the Clinical Evaluation of Drugs in Infants and Children (FDA197700A)	23

1976
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Date Issued	Title	Pages	Doc. (.pdf)
7/20/76	Guidelines for Reviewing Amendments to Include Plasmapheresis of Hemophiliacs (FDA197607A)	1

1973
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Date Issued	Title	Pages	Doc. (.pdf)
9/28/73	Interpretive Guidelines of the Additional Standards for Source Plasma (Human) & Guidelines for Informed Consent Forms, Source Plasma (Human) (FDA197309A)	8

Page Updated: July 10, 2008