Comparative assessment of off-label and unlicensed drug prescription in neonatal intensive care: FDA versus Brazilian guidelines

• Main Authors: Haline Tereza Matias Lima Costa (Author), Arlan Peres Florencio (Author), Priscilla Karilline do Vale Bezerra (Author), Jéssica Escorel Chaves Cavalcanti (Author), Tatiana Xavier Costa (Author), Flavia Evelyn Medeiros Fernandes (Author), Martins Rand Randall (Author)
• Format: Book
• Published: Elsevier, 2021-03-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Introduction: Regulatory agencies are responsible for defining the use of off-label (OL) and unlicensed (UL) drug prescription in neonatal intensive care. However, these regulatory criteria may differ between agencies in different countries. The aim of this study was to establish the frequency of OL...