Prior HIRA approval is required to administer Crysvita
By Lee, Tak-Sun | translator Kim, Jung-Ju
23.05.04 12:00:11
°¡³ª´Ù¶ó
0
Establishes a prior deliberation subcommittee for the drug... data submission is required even when administering the maintenance dose 1 year later
Accordingly, HIRA has prepared the specifics for Crysvita¡¯s prior approval and applied it from the 3rd of this month.
According to the specific criteria, medical institutions that seek to administer Crysvita¡¯s to children with X-linked hypophosphatemia (XLH), a rare inherited form of rickets, must apply for prior approval to HIRA.
The deliberation will be conducted by the Crysvita subcommittee under the Healthcare Review and Assessment Committee (HCRAC). The subcommittee will
Lee, Tak-Sun(hooggasi2@dailypharm.com)
If you want to see the full article, please JOIN US (click)