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Fig. 1 | Orphanet Journal of Rare Diseases

Fig. 1

From: A systematic review of real-world evidence (RWE) supportive of new drug and biologic license application approvals in rare diseases

Fig. 1

PRISMA diagram of inclusion and exclusion of NDAs and BLAs in the systematic review. Abbreviations: BLA, Biologic license application; CBER, Center for Biologics Evaluation and Research; CDER, Center for Drug Evaluation and Research; FDA, Food and Drug Administration,USA; n, Number of approvals; NDA, New drug application; ODD, Orphan drug designation; RWD, Real-world data. *Number of applications with the use of RWD for safety analysis were excluded, wherein RWD was used for prospective, post-marketing safety registry/data plans etc. Note: PRISMA diagram template was adapted from Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: https://doi.org/10.1136/bmj.n71

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Orphanet Journal of Rare Diseases

ISSN: 1750-1172