An Index of United States Federal Regulations and Guidelines Which Cover Safety Surveillance of Drugs
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Copyright 6D 1997 Drug Information Association Inc.
AN INDEX OF UNITED STATES FEDERAL REGULATIONS AND GUIDELINES WHICH COVER SAFETY SURVEILLANCE OF DRUGS CHARLESF. CURRAN, PHD Associate Director, Regulatory Affairs and Pharmacovigilance, Fujisawa USA, Inc., Deefield, Illinois
CINDYENGLE Associate Director, North American Product Surveillance. Glaxo Wellcome Inc., Research Triangle Park, North Carolina
An index is provided of relevant sections of ?It& 21, Code of Federal Regulations which cover the safety surveillance of drugs which are required of manufacturers in the United States. A relevant guideline and a guidance manual prepared by the Food and Drug Administration are also indexed. Key Words: United States regulations; Prescription drug safety; Code of Federal Regula-
tions
INTRODUCTION THIS IS AN INDEX of the United States federal regulations governing safety surveillance of drugs. It is intended to assist in locating the specific sections of the regulations which cover the various activities required of drug manufacturers and other affiliates 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 (2) and Compliance Program Guidance Manual ( 3 ) developed by the United States Food and Drug Administration as well as proposed regulations (4) and a relevant guideline published in the Federal Register ( 5 ) .
Use of this index is not intended to be a substitute for a careful and thorough review of applicable United States federal regulations governing safety surveillance of drugs, 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.
INDEX Table 1 lists the regulations, proposed regulations, and other documents which govern the safety surveillance of drugs. These documents are covered in this index (Table 2).
DISCUSSION Reprint address: Charles F. Curran. PhD, Fujisawa USA, Inc., Three Parkway North,Deerfield, IL 600152548.
Title 21 of the Code of Federal Regularions governs drug safety surveillance. In addition
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Charles F. Curran and Cindy Engle
TABLE 1 Regulations, Proposed Regulations, and Other Documents Which Govern the Safety Surveillance of Drugs Subject
Type
Regulations Regulations and Guideline Regulations Regulations Proposed Regulations Proposed Regulations Proposed Regulations Guideline
Other
Protection of the identities of reporters of adverse events and patients Postmarketing reporting of adverse drug experiences IND safety reports IND safety update reports to pending new drug applications Adverse events for marketed and prescription drugs without approved NDAs IND safety reports Postmarketing reporting of adverse drug experiences InternationalConference on Harmonization (ICH) G
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