Marketed Products

There also are numerous guidances regarding the review and reporting of adverse events for marketed products. The most important, but not all, of these guidances are

• CBER, Guidance for Industry—How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)

• CDER/CBER, Guidance for Industry—Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (1997)

• ICH, Guidance for Industry—E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (1996)

• CBER, Guideline for Adverse Experience Reporting for Licensed Biological Products (1993).

• CDER, Guidance for Industry—Guideline for Postmarketing Reporting of Adverse Drug Experiences (1992)

The guidances address issues such as how and when to submit safety reports and how FDA expects applicants to manage such issues as foreign reports, reports of deaths, overdoses, or lack of effect, and how to submit reports associated with multiple drugs.

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