Guidance for industry : E2BM data elements for transmission of individual case safety reports.

Format:

Book

Conference/Event

Government document

Contributor:

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

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

Conference Name:

International Conference on Harmonisation http://viaf.org/viaf/130234339

Language:

English

Subjects (All):

Clinical pharmacology.

Clinical trials--Reporting.

Clinical trials.

Drugs--Testing.

Drugs.

Physical Description:

1 online resource (34 pages)

Other Title:

E2BM data elements for transmission of individual case safety reports

Data elements for transmission of individual case safety reports

Place of 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, [2002]

Notes:

Title from PDF title page (viewed on June 19, 2009).

"ICH."

"April 2002."

"Revision 1."

OCLC:

404069629