The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates.
Ko WatanabeMasayasu MurakamiKoichi MasuyamaChieko IshiguroTsutomu MatsudaPublished in: Pharmacoepidemiology and drug safety (2018)
The significant association between pre-approval concerns and post-approval CSAR additions indicates that Japan's drug regulatory agency has generally conducted rigorous examination of the safety information available in the submitted data packages during drug review for approval.