Essential guidance on reporting adverse events — revised, refreshed and updated — in this brand-new edition for 2006.

Add Understanding FDA Drug and Biologic Adverse Event Regulations, 2006 Edition, a new book from FDAnews to your ready-reference shelf — it’s the best source for helping you and your staff make sense of often confusing reporting directives and protocols — and you’ll gain a greater sense of control over the adverse events reporting process.

This 2006 edition is packed with new guidance on:

• Electronic transmission of individual case safety reports (ICSRs) to the FDA — including specific information on how to construct the data elements for transmission
• Good pharmacovigilance practices and pharmacoepidemiologic assessment — including specific guidance on safety signal identification, pharmacoepidemiologic assessment and safety signal interpretation, and pharmacovigilance plan development
• Pharmacovigilance planning — describes a method for summarizing the identified risks of a drug, the potential for important unidentified risk and the potentially at-risk populations and situations that have not been studied preapproval
• Critical FDA guidance on use of the Risk Minimization Action Plans (RiskMAPs)

Table of Contents

Foreword

U.S. Federal Regulations

Section 1

Code of Federal Regulations Section Relevant to Adverse Events

FDA rules governing: records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications; investigational new drug applications and IND safety reports; and biological products and postmarketing reporting of adverse drug experiences.

U.S. Food & Drug Administration (FDA) Guidance

Section 2

Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines

FDA March 2001 draft guidance for industry, intended to assist applicants in fulfilling FDA’s existing postmarketing safety reporting requirements for human marketed drug and biological products. Specifically, discusses who must report, what is reported, reporting formats, special reporting situations, types of reports and coding.

Section 3

Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report

FDA August 1997 guidance for industry, created to clarify what information should be obtained before an individual case of an adverse experience should be considered for submission to the FDA and how safety information from solicited contacts with patients should be handled. Includes discussion of data elements and individual case reports.

Section 4

Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations and Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review

FDA September 1999 guidance to staff, designed to ensure that the agency is informed of all required adverse drug experience reports. Includes discussion of verification of reports and how to handle 483s and EIRs.

FDA February 2005 good review practice (GRP) guidance is intended to assist reviewers conducting the clinical safety reviews as part of the NDA and BLA review process, provide standardization and consistency in the format and content of safety reviews, and ensure that critical presentations and analyses will not be inadvertently omitted.

Section 5

Providing Regulatory Submissions in Electronic Format — Postmarketing Expedited Safety Reports

FDA May 2001 draft guidance for industry and November 2001 addendum, discussing general issues related to the electronic submission of postmarketing expedited safety reports for (1) drug products marketed for human use with new drug applications and abbreviated new drug applications, (2) prescription drug products marketed for human use without an approved NDA or ANDA, and (3) therapeutic biological products marketed for human use with biologic license applications.

Section 6

Providing Regulatory Submissions in Electronic Format — Postmarketing Periodic Adverse Drug Experience Reports

FDA June 2003 draft guidance for industry intended to assist applicants making regulatory submissions in electronic format to CDER and CBER. Discusses general issues related to the electronic submission of postmarketing periodic adverse drug experience reports for (1) drug products marketed for human use with new drug applications and abbreviated new drug applications and (2) therapeutic and blood products marketed for human use with biologics license applications.

Section 7

Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics

FDA May 2000 draft guidance for industry, intended to assist sponsors in developing the adverse reactions section of labeling for human prescription drugs and biologics. Includes information on content and format, organization, presentation and updating the adverse reactions section.

Section 8

Gene Therapy Patient Tracking System

FDA June 2002 document outlining objectives of the Gene Therapy Patient Tracking System — to supplement or replace current systems for assessing and promoting the safety of gene therapy so that the oversight system will be optimized for dealing with relatively specific gene therapy issues. Guidance discusses among other elements, role of drugs and biologics, including getting information during IND and similar stages.

Section 9

Premarketing Risk Assessment

FDA May 2004 draft guidance for industry on good risk assessment practices during the development of prescription products, including biological drug products. Specifically, discusses the generation, acquisition, analysis, and presentation of premarketing safety data. One of three guidances developed on risk management.

Section 10

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

FDA March 2005 draft guidance for industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products. Specifically, provides guidance on 1) safety signal identification, 2) pharmacoepidemiologic assessment and safety signal interpretation, and 3) pharmacovigilance plan development. One of three guidances developed on risk management.

Section 11

Development and Use of Risk Minimization Action Plans

FDA March 2005 draft guidance for industry on the development, implementation, and evaluation of risk minimization action plans for prescription drug products, including biological drug products. In particular, gives guidance on 1) initiating and designing plans to minimize known risks (e.g., risk minimization action plans or RiskMAPs), 2) selecting and developing tools to minimize those risks, 3) evaluating and monitoring tools and RiskMAPs, and 4) the recommended components of a RiskMAP submission to FDA. One of three guidances developed on risk management.

International Conference on Harmonisation (ICH) Guidance

Section 12

E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

ICH March 1995 guideline for industry, created to harmonize the way to gather and take action on important clinical safety information arising during clinical development. The included definitions and procedures are intended to ensure uniform Good Clinical Practice standards.

Section 13

E2BM: Data Elements for Transmission of Individual Case Safety Reports

ICH April 2002 guidance for industry, intended to assist applicants submitting individual case safety reports to FDA. Includes information on requirements for content of the data elements and examples of tabular representations.

Section 14

E2B(M): Data Elements for Transmission of Individual Case Safety Reports — Questions and Answers

ICH March 2005 Question and Answer guidance for industry intended to assist applicants who plan the electronic transmission of individual case safety reports. Provides answers to questions that have arisen since the finalization of the ICH E2B(M) guidance, version 4.4.1, and the M2 specification document, version 2.3

Section 15

E2C: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs

ICH November 1996 guidance and 2002 Addendum for industry on the format and content of PSURs – particularly suitable for comprehensive reports covering short periods (e.g., 6 months, 1 year) often prepared during the initial years following approval/authorization. Includes a model PSUR, glossary of special terms and example of a presentation of worldwide marketing authorization status.

Section 16

Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs

ICH February 2004 addendum to 1996 guidance for industry, providing practical guidance for the preparation of PSURs as recommended in the ICH guidance E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs.

Section 17

Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

ICH July 2003 draft guidance based on the content of ICH E2A with consideration as to how the terms and definitions can be applied in the post-approval phase of the product life cycle. Along with definitions, includes standards for expedited reporting and good case management practice.

Section 18

ICH E2E: Pharmacovigilance Planning (PvP) and Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others

ICH April 2005 draft guidance intended to aid industry and regulators in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug. Describes a method for summarizing the identified risks of a drug, the potential for important unidentified risks, and the potentially at-risk populations and situations that have not been studied pre-approval.

FDA October 2005 draft guidance provides direction about HHS regulations for the protection of human research subjects (45 CFR part 46) related to the review and reporting of (a) adverse events, and (b) unanticipated problems involving risks to subjects or others.