| Autor: |
Fukaya‐Shiba, Ai, Shimokawa, Masafumi, Sasaki, Hajime, Wakao, Rika |
| Předmět: |
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| Zdroj: |
British Journal of Clinical Pharmacology; Mar2022, Vol. 88 Issue 3, p1392-1394, 3p |
| Abstrakt: |
Although MSC-derived EVs per se may deliver therapeutic benefits, there exist some caveats.6 Thus, the Science Board will discuss the following: Identity of EVs: Owing to the heterogeneous nature of EVs, their regulatory scope should be clarified 7 for their therapeutic use. To address the emerging issues, PMDA is cooperating with the International Coalition of Medicines Regulatory Authorities (ICMRA).10 As a member of ICMRA, PMDA is going to deliver the PTC for the development of EV therapy. Keywords: drug development; horizon scanning; regulatory science EN drug development horizon scanning regulatory science 1392 1394 3 02/21/22 20220301 NES 220301 We read with interest the recent article by Hidalgo-Simon and Fibbe,1 who proposed academia's involvement with regulation for promoting advanced therapy development. [Extracted from the article] |
| Databáze: |
Complementary Index |
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