TY  - JOUR
T1  - Navigating regulatory challenges in molecularly tailored nanomedicine
AU  - Singh, Ajay Vikram
AU  - Bhardwaj, Preeti
AU  - Upadhyay, Aditya Kumar
AU  - Pagani, Anselmo
AU  - Upadhyay, Jyoti 
AU  - Bhadra, Jolly
AU  - Tisato, Veronica
AU  - Thakur, Manali
AU  - Gemmati, Donato
AU  - Mishra, Rudresh
AU  - Zamboni, Paolo
Y1  - 2024///
JO  - Exploration of BioMat-X
VL  - 1
IS  - 2
SP  - 124
EP  - 134
DO  - 10.37349/ebmx.2024.00009
UR  - https://www.explorationpub.com/Journals/ebmx/Article/10139
AB  - Nanomedicine, a convergence of nanotechnology and medical sciences, has unleashed transformative potential in healthcare. However, harnessing the benefits of nanomedicine requires a thorough understanding of its regulatory landscape. An in-depth discussion of regulatory considerations, including molecular safety assessment, harmonization of the regulatory landscape, and shaping the future of innovation, is presented in this discourse. The molecular safety assessment entails evaluating interactions between nanoparticles and biomolecules, ensuring compatibility at the molecular level. Harmonization involves developing international standards and guidelines for a consistent regulatory approach, while shaping innovations emphasizes integrating molecular safety assessments into early stages of development. Challenges encompass the need for standardized assessment methods, balancing innovation with safety, and addressing unique features of novel molecular designs. As the nanomedicine landscape evolves, effective regulatory strategies must navigate the intricate interplay of molecules and technologies, ensuring both patient access and product safety.
ER  -