%0 Journal Article %1 noauthororeditor %A P, Vikram Biradar | S. Vignesh | Santhosh Kumar %D 2023 %J INTERNATIONAL JOURNAL OF TREND IN SCIENTIFIC RESEARCH AND DEVELOPMENT %K Adaptive Approval Complex Ethical Genetic International Pricing Regulatory Safety accessibility, and approaches, authorities, collaboration, considerations, dilemmas, diseases disorders, editing generation landscape, processes, regulatory technologies, therapies, %N 4 %P 658-662 %T Regulatory Landscape for Gene Therapies Current Status and Future Prospects %U https://www.ijtsrd.com/biological-science/other/59768/regulatory-landscape-for-gene-therapies-current-status-and-future-prospects/vikram-biradar %V 7 %X Gene therapies hold tremendous potential as revolutionary treatments for genetic disorders and inherited diseases, promising to address the underlying causes of conditions rather than just managing symptoms. As the field of gene therapy rapidly advances, establishing a robust and adaptive regulatory landscape becomes crucial to ensure patient safety, efficacy, and equitable access to these transformative therapies. This article provides an overview of the current regulatory landscape for gene therapies, covering key topics such as regulatory authorities and approval processes, safety considerations, pricing and accessibility challenges, ethical dilemmas, and the role of international collaboration and harmonization efforts. Moreover, the article discusses future prospects, including advancements in gene editing technologies, adaptive regulatory approaches, and regulatory considerations for complex diseases. Collaborative efforts among regulators, researchers, clinicians, patients, and industry stakeholders are essential to navigate the regulatory challenges and harness the full potential of gene therapies for the betterment of human health. Vikram Biradar | S. Vignesh | Santhosh Kumar P "Regulatory Landscape for Gene Therapies: Current Status and Future Prospects" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, URL: https://www.ijtsrd.com/papers/ijtsrd59768.pdf Paper Url:https://www.ijtsrd.com/biological-science/other/59768/regulatory-landscape-for-gene-therapies-current-status-and-future-prospects/vikram-biradar

@article{noauthororeditor, abstract = {Gene therapies hold tremendous potential as revolutionary treatments for genetic disorders and inherited diseases, promising to address the underlying causes of conditions rather than just managing symptoms. As the field of gene therapy rapidly advances, establishing a robust and adaptive regulatory landscape becomes crucial to ensure patient safety, efficacy, and equitable access to these transformative therapies. This article provides an overview of the current regulatory landscape for gene therapies, covering key topics such as regulatory authorities and approval processes, safety considerations, pricing and accessibility challenges, ethical dilemmas, and the role of international collaboration and harmonization efforts. Moreover, the article discusses future prospects, including advancements in gene editing technologies, adaptive regulatory approaches, and regulatory considerations for complex diseases. Collaborative efforts among regulators, researchers, clinicians, patients, and industry stakeholders are essential to navigate the regulatory challenges and harness the full potential of gene therapies for the betterment of human health. Vikram Biradar | S. Vignesh | Santhosh Kumar P "Regulatory Landscape for Gene Therapies: Current Status and Future Prospects" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, URL: https://www.ijtsrd.com/papers/ijtsrd59768.pdf Paper Url:https://www.ijtsrd.com/biological-science/other/59768/regulatory-landscape-for-gene-therapies-current-status-and-future-prospects/vikram-biradar }, added-at = {2023-10-14T13:02:17.000+0200}, author = {P, Vikram Biradar | S. Vignesh | Santhosh Kumar}, biburl = {https://www.bibsonomy.org/bibtex/2acdce16920675e2b66f32125af8a7b82/ijtsrd}, interhash = {0eae401c0287aaa60b8aa16df3abe6ae}, intrahash = {acdce16920675e2b66f32125af8a7b82}, issn = {2456-6470}, journal = {INTERNATIONAL JOURNAL OF TREND IN SCIENTIFIC RESEARCH AND DEVELOPMENT}, keywords = {Adaptive Approval Complex Ethical Genetic International Pricing Regulatory Safety accessibility, and approaches, authorities, collaboration, considerations, dilemmas, diseases disorders, editing generation landscape, processes, regulatory technologies, therapies,}, language = {english}, month = aug, number = 4, pages = {658-662}, timestamp = {2023-10-14T13:02:17.000+0200}, title = {Regulatory Landscape for Gene Therapies Current Status and Future Prospects }, url = {https://www.ijtsrd.com/biological-science/other/59768/regulatory-landscape-for-gene-therapies-current-status-and-future-prospects/vikram-biradar}, volume = 7, year = 2023 }