A Comprehensive Retrospective Analysis of Trends and Strategic Implications of 505(b)(2) Approvals (2019–2023)

Ramesh Joga, Kailas Vijay Gadekar, Kajal Gandhi, M. Sowndharya, Sonali Waikar, Rajeev Singh Raghuvanshi, Saurabh Srivastava

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DOI: 10.1007/s43441-025-00775-1
Published: 2025-05-05
Container: Therapeutic Innovation & Regulatory Science
Publisher: Springer Science and Business Media LLC
Open access: unknown

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Cite this work

BibTeX

@article{allodium:10.1007/s43441-025-00775-1,
  title = {A Comprehensive Retrospective Analysis of Trends and Strategic Implications of 505(b)(2) Approvals (2019–2023)},
  author = {Ramesh Joga and Kailas Vijay Gadekar and Kajal Gandhi and M. Sowndharya and Sonali Waikar and Rajeev Singh Raghuvanshi and Saurabh Srivastava},
  year = {2025},
  journal = {Therapeutic Innovation \&amp; Regulatory Science},
  doi = {10.1007/s43441-025-00775-1},
  url = {https://doi.org/10.1007/s43441-025-00775-1}
}

RIS

TY  - JOUR
TI  - A Comprehensive Retrospective Analysis of Trends and Strategic Implications of 505(b)(2) Approvals (2019–2023)
AU  - Ramesh Joga
AU  - Kailas Vijay Gadekar
AU  - Kajal Gandhi
AU  - M. Sowndharya
AU  - Sonali Waikar
AU  - Rajeev Singh Raghuvanshi
AU  - Saurabh Srivastava
PY  - 2025
JO  - Therapeutic Innovation &amp; Regulatory Science
DO  - 10.1007/s43441-025-00775-1
UR  - https://doi.org/10.1007/s43441-025-00775-1
ER  -

APA

Joga, R., Gadekar, K. V., Gandhi, K., Sowndharya, M., Waikar, S., Raghuvanshi, R. S., & Srivastava, S. (2025). A Comprehensive Retrospective Analysis of Trends and Strategic Implications of 505(b)(2) Approvals (2019–2023). Therapeutic Innovation & Regulatory Science. https://doi.org/10.1007/s43441-025-00775-1

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crossref · retrieved 2026-09-27T09:51:11.815Z