00599nas a2200109   4500000000100000000000100001008004100002260000900043100007600052245018800128856017300316       2015                            d  c20151 aUS Food and Drug Administration Center for Drug Evaluation and Research00aNonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route: Guidance for Industry and Review Staff Good Review Practice  uhttps://www.fda.gov/files/drugs/published/Nonclinical-Safety-Evaluation-of-Reformulated-Drug-Products-and-Products-Intended-for-Administration-by-an-Alternate-Route.pdf