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003 OCoLC;

005 20090619150030.0;

006 m d f ;

007 cr a||||||||||;

008 090619s2004 mdu o f000 0 eng d;

040 a| GPOc| GPOd| MvI;

049 a| ERE#;

074 a| 0499-T (online);

086 0 a| HE 20.4702:D 26/4;

245 00 a| Guidance for industry :b| addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs.;

246 30 a| Clinical safety data management;

246 30 a| Periodic safety update reports for marketed drugs;

260 a| Rockville, MD :b| U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :b| Center for Biologics Evaluation and Research,c| [2004];

300 a| 9 p. :b| digital, PDF file;

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

538 a| Mode of access: Internet at the FDA web site. Address as of 6/19/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129446.pdf ; current access is available via PURL.;

500 a| Title from PDF title page (viewed on June 19, 2009).;

500 a| "ICH".;

500 a| "February 2004".;

500 a| GPO Cataloging Record Distribution Program (CRDP).;

650 0 a| Clinical pharmacology.=| ^A807728;

650 0 a| Drugsx| Side effectsx| Reporting.=| ^A888184;

650 0 a| Drugsx| Testing.=| ^A4660;

710 2 a| Center for Drug Evaluation and Research (U.S.)=| ^A431016;

710 2 a| Center for Biologics Evaluation and Research (U.S.)=| ^A368272;

711 2 a| International Conference on Harmonisation.=| ^A998855;

856 40 u| https://purl.fdlp.gov/GPO/LPS113936;

949 a| Click on web addressw| asish| joyner94;

596 a| 1;

998 a| 1900591;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 1900591-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 9/16/2009x| EDOCUMENTz| JERESOURCEo| .STAFF. jlhb;

Guidance for industry : addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs.

Other author	Center for Drug Evaluation and Research (U.S.)
Other author	Center for Biologics Evaluation and Research (U.S.)
Other author	International Conference on Harmonisation.
Format	Electronic
Publication Info	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, [2004]
Description	9 p. : digital, PDF file
Supplemental Content	https://purl.fdlp.gov/GPO/LPS113936
Subjects	Clinical pharmacology. Drugs--Side effects. --Reporting. Drugs--Testing.

Portion of title	Clinical safety data management
Portion of title	Periodic safety update reports for marketed drugs
General note	Title from PDF title page (viewed on June 19, 2009).
General note	"ICH".
General note	"February 2004".
General note	GPO Cataloging Record Distribution Program (CRDP).
Technical details	Mode of access: Internet at the FDA web site. Address as of 6/19/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129446.pdf ; current access is available via PURL.
GPO item number	0499-T (online)
Govt. docs number	HE 20.4702:D 26/4

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Guidance for industry : addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs.

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