An Index of United States Federal Regulations and Guidelines Which Cover Clinical Safety Surveillance of Biological Prod
- PDF / 302,404 Bytes
- 5 Pages / 504 x 719.759 pts Page_size
- 43 Downloads / 162 Views
0092-86 15/97 Copyright 0 1997 Drug Information Association Inc.
AN INDEX OF UNITED STATES FEDERAL REGULATIONS AND GUIDELINES WHICH COVER CLINICAL SAFETY SURVEILLANCE OF BIOLOGICAL PRODUCTS CHARLES
F. C U R R A N , PHD
Associate Director, Regulatory Affairs and Pharmacovigilance, Fujisawa USA, Inc., Deerfield, Illinois
JUDITH M. SILLS,PHARMD Senior Director, Product Safety Surveillance and Information, Warner-Lambert Company, Morns Plains, New Jersey
An index is provided covering relevant sections of 7itle 21, Code of Federal Regulations governing the safety surveillance of biological products which are required of munufacturers in the United States. This index also covers relevant guidelines published by the United States Food and Drug Administration. Key Words: United States regulations; Biological products safety; Code of Federal Regulations; Food and Drug Administration
INTRODUCTION THIS IS AN INDEX of the United States federal regulations governing clinical safety surveillance of biological products. It is intended to assist in locating the specific sections of the regulations which cover the various activities required of biological product manufacturers in the receiving, processing, and filing of safety information, and in the reporting of safety information to the Food and Drug Administration (FDA) (1). The index also covers a relevant guideline published by the Center for Biologics Evaluation and Research (CBER) of the FDA (2). Use of this index is not intended to be a substitute for a careful and thorough review
Reprint address: Charles F. Curran, PhD, Fujisawa USA, h c . . Three Parkway North, Deerfield, IL 600152548.
of applicable United States federal regulations governing safety surveillance of biological products, whether or not they are included in this index. This index is not endorsed by any regulatory agency or other organization and is offered to facilitate familiarization with applicable United States federal regulations. In addition to the above two abbreviations, the following abbreviations are used in this index: CIOMS-Council of International Organizations of Medical Science, ICD-International Classification of Diseases, MMWR-Morbidity and Mortality Weekly Report, VAERS-Vaccine Adverse Event Reporting System, and 0 WHO-World Health Organisation. 0
843 Downloaded from dij.sagepub.com at NANYANG TECH UNIV LIBRARY on May 21, 2015
844
Charles F. Curran and Judith M. Sills
TABLE 1 Regulations and the Guideline Pertaining to Postmarketing Reporting of Adverse Experiences for Biological Products 3-Day Alert Report, 600.80(c)(l)(iii) Submitting report by manufacturer, 600.80(c)(l)(iii) Submitting report by licensed manufacturer, 600.80(c)(l)(iii) Requirements for submitting report, 600.80(c)(l)(iii) 15-Day Alert Report, 600.80(c)(l)(l) Serious and unexpected, 600.80(c)(l)(l), October 15, 1993 Guideline, pp. 2, 11-12 FDA reporting form, 600.80(c)(l)(l), October 15, 1993 Guideline, p. 11 Format, 600.80(c)(1)(I) VAERS form, 600.80(c)(l)(I), October 15, 1993 Guideline, p. 11 Follow-up repo
Data Loading...
