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Guidance Issuing OfficeCenter for Veterinary Medicine
The VICH Guidance GL24, Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AERs), defines the Periodic Summary Update (PSU).
Based on this definition, using the terminologies as defined in the GL24 document, this document gives guidance related to the scope, timing and contents of the PSU.
The scope of pharmacovigilance in this VICH document is defined as the management of the detection and investigation of the clinical effects of marketed veterinary medicinal products (VMPs) mainly concerned with the safety and efficacy in animals and the safety in people exposed to these products. While pharmacovigilance in its broadest sense may entail a wide range of activities, this document deals with the spontaneous reporting system for the identification of possible adverse events following the use of marketed VMPs.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2001-D-0398.