Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Dec;18(12):2101-2104.
doi: 10.15252/embr.201745345. Epub 2017 Nov 9.

Advanced therapies push regulatory boundaries: Novel therapeutic approaches require more regulatory flexibility and transparency

Philip Hunter  1
Affiliations

Advanced therapies push regulatory boundaries: Novel therapeutic approaches require more regulatory flexibility and transparency

Philip Hunter. EMBO Rep. 2017 Dec.

Abstract

Novel therapies, such as gene or cell therapy, don not require radical changes of the regulatory framework for medicinal products. Yet, both new and old developments cannot be easily accommodated by existing regulations.

PubMed Disclaimer

Similar articles

See all similar articles

References

    1. Cawood R, Hills T, Wong SL, Alamoudi AA, Beadle S, Fisher KD, Seymour LW (2012) Recombinant viral vaccines for cancer. Trends Mol Med 18: 564–574 - PubMed
    1. Behaegel J, Dhubhghaill SN, Koppen C, Zakaria N (2017) Safety of cultivated limbal epithelial stem cell transplantation for human corneal regeneration. Stem Cells Int 2017: 6978253 - PMC - PubMed
    1. Chan YY, Sandlin SK, Kurzrock EA, Osborn SL (2017) The current use of stem cells in bladder tissue regeneration and bioengineering. Biomedicines 5: 4 - PMC - PubMed
    1. Rodriguez E (2016) Ethical issues in genome editing using Crispr/Cas9 system. J Clin Res Bioeth 7: 266
    1. Cattaneo E, Corbellini G (2014) Stem cells: taking a stand against pseudoscience. Nature 510: 333–335 - PubMed

LinkOut - more resources