Zdrowie i gospodarka · 09/01/2006

FDA Proposes Reclassification of Herpes Simplex Virus (HSV) Serological Assays

The Food and Drug Administration (FDA) is proposing to change the regulatory status of herpes simplex virus (HSV) serological assays from a premarket approval requirement to a special controls requirement, based on new information and in an effort to facilitate the development of these assays.