TY - JOUR AU - Nightingale, Stuart L. AB - From the Food and Administration Drug Guideline for the Moni¬ lection kits for immuno¬ actual would be in New FDA test test not acquired performed Clinical The of criteria the home but in a of Investigations: deficiency syndrome (AIDS) laboratory.) toring FDA is available of the kits. The a to making document, applicable approval Over-the-Counter Loperamide Ap¬ "Guideline for the of Clinical believes that such kits Monitoring agency currently The FDA an proved: recently approved which describes must be used within a Investigations," ap¬ comprehensive over-the-counter oral dos¬ (OTC), liquid the FDA for health care environment must to and proaches acceptable pro¬ in a formulation age loperamide product in¬ and of clinical vide for monitoring investigations reporting interpretation that been available had previously by the results as well as for a volving any FDA-regulated product— counseling by The has found that prescription. agency human med¬ health care The drugs, biological products, professional provider. labeled OTC properly loperamide may ical food color addi¬ the criteria: devices, additives, agency specified following be used and for acute safely effectively Kits be labeled and marketed and The 1. must guide¬ tives, veterinary drugs. diarrhea consumers nonspecific by line intended facilitate for use within TI - From the Food and Drug Administration JF - JAMA DO - 10.1001/jama.1988.03720220007006 DA - 1988-06-10 UR - https://www.deepdyve.com/lp/american-medical-association/from-the-food-and-drug-administration-zYuMLjdVxE SP - 3231 EP - 3231 VL - 259 IS - 22 DP - DeepDyve ER -