They are usually granted with the assumption that clinical trials for the drug or medical product are currently under way and upon the conclusion of those trials, a decision regarding FDA approval will be made.
Imvamisa banikezwa ngomcabango wokuthi izivivinyo zokwelashwa komuthi noma umkhiqizo wezokwelapha ziyaqhubeka njengamanje futhi lapho kuphela lezo zivivinyo, kuzothathwa isinqumo mayelana nokuvunyelwa kwe-FDA.