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."

1989
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Date Issued	Title	Pages	Document (.pdf)
9/89	Guideline for Drug Master Files FDA198909A	33

1988
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Date Issued	Title	Pages	Document (.pdf)
11/1/88	Draft Guideline for the Design of Clinical Trials for Evaluation of Safety and Efficacy of Allergenic Products for Therapeutic Uses FDA198811A	23
10/21/88	Investigational New Drug, Antibiotic, and Biological Drug Product Regulations; Procedures for Drugs Intended to Treat Life-Threatening and Severely Debilitating Illnesses (Federal Register Document - Interim Rule) (FDA198810Bfr)	9
10/7/88	Guideline for the Collection of Platelets, Pheresis Prepared by Automated Methods (FDA198810A)	12
7/88	Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications (FDA198807A)	134
1/88	Guideline for the Monitoring of Clinical Investigations (FDA198801A)	6

1987
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Date Issued	Title	Pages	Document (.pdf)
12/1/87	Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices (FDA198712A)	43
11/87	Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (DRAFT) (FDA198711A)	13
6/87	Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (FDA198706B)	23
6/1/87	Guideline on Sterile Drug Products Produced by Aseptic Processing (FDA198706A)	44
5/1/87	Guideline on General Principles of Process Validation (FDA198705A)	26
2/1/87	Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics (FDA198702A)	29
2/1/87	Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics (*Withdrawn 6/1/06 FDA198702C)	60
2/87	Guideline for the Format and Content of the Chemistry, Manufacturing and Control Section of an Application *Withdrawn 6/1/06 FDA198702B)	13
2/87	Guideline for the Format and Content of the Microbiology Section of an Application (FDA198702D)	9
2/87	Guideline for the Format and Content of the Non clinical Pharmacology/Toxicology Section of an Application (FDA198702E)	30
2/87	Guideline for the Format and Content of the Summary for New Drug and Antibiotic Applications (FDA198702F)	27
2/87	Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (FDA198702G)	16
2/87	Guideline on Formatting, Assembling, and Submitting New Drug and Antibiotic Applications (FDA198702H)	36
2/87	Guideline for Submitting Documentation for the Manufacture of and Controls for Drug Products (FDA198702I)	20
2/87	Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances (FDA198702J)	64
2/87	Guideline for Submitting Samples and Analytical Data for Methods Validation (FDA198702K)	19

1985
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Date Issued	Title	Pages	Document (.pdf)
8/1/85	Guideline for the Uniform Labeling of Blood and Blood Components FDA198508A	80
7/17/85	Guidelines for Meningococcal Polysaccharide Vaccines FDA198507A	24
4/10/85	Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology (FDA198504A)	14

1984
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Date Issued	Title	Pages	Document (.pdf)
6/1/84	Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products FDA198406A	13

1983
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Date Issued	Title	Pages	Document (.pdf)
7/28/83	Points to Consider in the Production and Testing of Interferon Intended for Investigational Use in Humans FDA198307A	21
6/20/83	Points to Consider in the Manufacture of In Vitro Monoclonal Antibody Products Subject to Licensure FDA198306A	5

1981
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Date Issued	Title	Pages	Document (.pdf)
8/81	Revised Guideline for Adding Heparin to Empty Containers for Collection of Heparinized Source Plasma (Human) (FDA198108A)	2
7/81	Platelet Testing Guidelines (FDA198107A)	6
6/81	Good Laboratory Practice Regulations Questions and Answers (FDA198106A)	27
1/81	Guidelines for the Collection of Human Leukocytes for Further Manufacturing (FDA198101A)	5

1980
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Date Issued	Title	Pages	Document (.pdf)
6/80	Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances (FDA198006A)	9

Page Updated: March 3, 2010