Editing Nanomedicine (section)

== Regulatory Impacts ==
As the development of nanomedicine continues to develop and becomes a potential treatments for diseases, regulatory challenges have come to light. This section will highlight some of the regulatory considerations and challenges faced by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and each manufacturing organization. The major challenges that companies are reproducible manufacturing processes, scalability, availability of appropriate characterization methods, safety issues, and poor understandings of disease heterogeneity and patient preselection strategies.<ref name=":3">{{Cite journal |last1=Agrahari |first1=Vibhuti |last2=Agrahari |first2=Vivek |date=2018-05-01 |title=Facilitating the translation of nanomedicines to a clinical product: challenges and opportunities |url=https://linkinghub.elsevier.com/retrieve/pii/S1359644617302295 |journal=Drug Discovery Today |volume=23 |issue=5 |pages=974–991 |doi=10.1016/j.drudis.2018.01.047 |pmid=29406263 |issn=1359-6446}}</ref> Despite these challenges, several therapeutic nanomedicine products have been approved by the FDA and EMA.<ref name=":3" /><ref name=:5>{{Cite journal |last1=Bowman |first1=Diana M |last2=Gatof |first2=Jake |date=2015-11-01 |title=Reviewing the Regulatory Barriers for Nanomedicine: Global Questions and Challenges |url=https://www.tandfonline.com/doi/full/10.2217/nnm.15.169 |journal=Nanomedicine |volume=10 |issue=21 |pages=3275–3286 |doi=10.2217/nnm.15.169 |issn=1743-5889 |pmid=26470990}}</ref> In order to be approved for market, these therapies are evaluated for biocompatibility, immunotoxicity, as well as undergo a preclinical assessment.<ref>{{Cite journal |last1=Sainz |first1=Vanessa |last2=Conniot |first2=João |last3=Matos |first3=Ana I. |last4=Peres |first4=Carina |last5=Zupanǒiǒ |first5=Eva |last6=Moura |first6=Liane |last7=Silva |first7=Liana C. |last8=Florindo |first8=Helena F. |last9=Gaspar |first9=Rogério S. |date=2015-12-18 |title=Regulatory aspects on nanomedicines |url=https://linkinghub.elsevier.com/retrieve/pii/S0006291X15304137 |journal=Biochemical and Biophysical Research Communications |volume=468 |issue=3 |pages=504–510 |doi=10.1016/j.bbrc.2015.08.023 |pmid=26260323 |issn=0006-291X}}</ref> 

The current scope of approved nanomedicine are mainly nano-drugs, but as the field continued to grow and more applications of nanomedicine progress to a marketable scale, more impacts and regulatory oversight will be needed.<ref name=":5" /><ref>{{Cite book |last1=Hodge |first1=Graeme |title=International handbook on regulating nanotechnologies |last2=Bowman |first2=Diana |last3=Maynard |first3=Andrew |date=December 1, 2010 |publisher=Edward Elgar Publishing Ltd. |isbn=9781848446731}}</ref>