Zdrowie i gospodarka · 17.06.2016
Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of guidance for industry #238 entitled "Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications." This guidance provides recommendations on the submission of chemistry, manufacturing, and controls and pharmacokinetic information, as well as procedures to follow, to support the approval of modified release parenteral drug products intended for use in veterinary species. This guidance is applicable to both new animal drug applications and abbreviated new animal drug application products.