TY - JOUR AU - Nightingale, Stuart L. AB - From the Food and Administration Drug for Treatment Use of Inves- of the United States. Ivermectin is sists of a kit for urine collection and mail¬ Proposal ap¬ Devices: FDA The has is- for the treatment of intestinal a and a tigational proved ing, laboratory testing service, sued a to make certain inves- results and referral service. Directions nondisseminated) proposal (ie, strongyloidiasis, devices available under based on clinical studies in which 64% for use and for and tigational obtaining interpret¬ and circumstances similar to to 100% of infected were cured results are included in the kit. Us¬ procedures patients ing those authorized for inves- a of the ers of the kits send the a dose to previously following single 200-ug/kg specimens the as of "Treat- The discusses which screens tigational drugs part drug. approved labeling designated laboratory, IND" The in- the ment need for stool examina¬ them on an automated for agency's program. repeated analyzer and, is facilitate tent to the of tions to document clearance of infection all that confirms the re¬ availability test positive, and and also new mentions that treatment of sults promising therapeutic diagnos- by gas chromatography/mass spec- tic devices ill be- to in a TI - From the Food and Drug Administration JF - JAMA DO - 10.1001/jama.1997.03540330027012 DA - 1997-03-05 UR - https://www.deepdyve.com/lp/american-medical-association/from-the-food-and-drug-administration-sPXed0Hoac SP - 703 EP - 703 VL - 277 IS - 9 DP - DeepDyve ER -