CDISC-Gloss – The date of the first marketing authorization for a new product granted to any company in any country in the world. NOTE: Used for Periodic Safety Update Report (PSUR). [After ICH E2C(R2), Appendix A]
CDISC-Gloss – The date of the first marketing authorization for a new product granted to any company in any country in the world. NOTE: Used for Periodic Safety Update Report (PSUR). [After ICH E2C(R2), Appendix A]