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Subjects (1-6 of 6)
Clinical trials -- Reporting -- Government policy -- United States.
1
2001
E-REPORT
Guidance for industry M4Q, the CTD, quality.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
2
2001
E-REPORT
Guidance for industry M4S, the CTD, safety.
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, [2001]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
3
2001
E-REPORT
Guidance for industry M4S, the CTD, safety appendices.
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, [2001]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
4
1998?
E-REPORT
Information sheet guidance for institutional review boards and clinical investigators (acceptance of
[Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, 1998?]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
5
2005
E-REPORT
Reviewer guidance conducting a clinical safety review of a new product application and preparing a r
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2005]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
6
1996
E-REPORT
Structure and content of clinical study reports
[Rockville, Md : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 1996]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
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