ANTI-TOXOPLASMA IGM TEST LABELING CHANGES MUST BE MADE BY JULY, FDA TELLS MANUFACTURERS; RESULTS OF FDA/CDC TEST SENSITIVITY STUDY DUE BY MID-1997
This article was originally published in The Gray Sheet
Executive Summary
Labeling changes to clarify performance limitations of anti-Toxoplasmosis gondii IgM antibody tests "should be in effect within six months, or the next printing of [test] labeling, whichever occurs first," FDA says in a letter sent to manufacturers the week of Jan. 13.