Zdrowie i gospodarka · 11/23/1994
Methods of the Allergenic Products Testing Laboratory; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Methods of the Allergenic Products Testing Laboratory'' (the methods document), dated October 1993. The methods document provides the technical details for performing in vivo and in vitro analytical methods acceptable to FDA to ensure the identity and relative potency of allergenic extracts. The methods document is intended for use by manufacturers of licensed allergenic extracts, sponsors of investigational new drug applications for allergenic extracts, and other interested parties.