Research Catalog

Title

Guidance for industry : integrated summaries of effectiveness and safety : location within the common technical document.

Publication

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2009]

Details

Additional Authors

• Center for Drug Evaluation and Research (U.S.)
• Center for Biologics Evaluation and Research (U.S.)

Description

7 pages : digital, PDF file

Alternative Title

Integrated summaries of effectiveness and safety

Subject

• Drugs > Effectiveness > United States
• Biologicals > Effectiveness > United States

Note

• Title from title page (viewed on May 4, 2009).
• "Procedural."
• "April 2009."

Bibliography (note)

• Includes bibliographical references.

System Details (note)

• Mode of access: Internet at the FDA CDER web site. Address as of 5/4/09: http://www.fda.gov/cder/guidance/8524fnl.pdf; current access is available via PURL.

Call Number

GPO Internet HE 20.4702:IN 8/2

OCLC

marcive320136370

Title

Guidance for industry : integrated summaries of effectiveness and safety : location within the common technical document.

Publisher

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2009]

Type of Content

text

Type of Medium

computer

Type of Carrier

online resource

System Details

Mode of access: Internet at the FDA CDER web site. Address as of 5/4/09: http://www.fda.gov/cder/guidance/8524fnl.pdf; current access is available via PURL.

Bibliography

Includes bibliographical references.

Connect to:

https://purl.fdlp.gov/GPO/LPS112211

Added Author

Center for Drug Evaluation and Research (U.S.)

Center for Biologics Evaluation and Research (U.S.)

Gpo Item No.

0499-T (online)

Sudoc No.

HE 20.4702:IN 8/2