Clinical trial safety surveillance in the new regulatory and harmonization environment: Lessons learned from the 'fialuridine crisis'

Drug Information Journal

Volumn 31, Issue 1, 1997, Pages 63-70

  Nickas, James ^a  

^a GENENTECH INC   (United States)

Author keywords

Adverse event reporting; Case report forms; Clinical trials; FDA proposed rule; Fialuridine; Harmonization; Safety surveillance

Indexed keywords

FIALURIDINE;

DRUG INDUSTRY; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; LAW; LIVER TOXICITY; MORTALITY; PRIORITY JOURNAL; REVIEW;

EID: 0031053664     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100110     Document Type: Review

References (9)

1. International Conference on Harmonization. Guideline on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. Notice. Federal Register. March 1, 1995 (Docket No. 93D-0203).
2. Food and Drug Administration. Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products. Proposed Rule. Federal Register. October 27, 1994 (Docket No. 93N-0181).
3. Spilker B. Guide to Clinical Trials. New York: Raven Press, 1991.
4. International Conference on Harmonization. Draft Document on Good Clinical Practices: Notice. Federal Register. August 17, 1995 (Docket No. 95D-0219).
5. Food and Drug Administration. Guideline for the Format and Content of the Clinical and Statistical Sections of an Application. July 1988.
6. 21 CRF §312.64(b).
7. Littlejohn JK, Lucas DO, Batson-Fowler G, Edwards S. Adverse experience collection: perspective from a biological development program. Drug Inf J. 1991; 25:175-180.
8. Nickas J. Adverse event data collection and reporting: A discussion of two grey areas. Drug Inf J. 1995;29: 1247-1251.
9. Guarino RA. Clinical study conduct/procedures. Drug Inf J. 1994;28:481-488.