United States: an accelerated process to market gene and cell therapies

Publié le 6 Dec, 2017

Last week, the US Food and Drug Administration (FDA) announced the implementation of an accelerated review process for gene therapies and regenerative medical treatments.


The purpose of these new guidelines is to accelerate the marketing of “effective gene therapies”. To date, the FDA has authorised two of these treatments (see United States: a second gene therapy is launched). At the same time, stem cell therapies to treat serious, incurable diseases may also benefit from this accelerated process. The FDA nevertheless remains vigilant and intends to clamp down on fraudulent clinics offering unchecked, often risky procedures mostly involving the use of adult stem cells derived from fatty tissue. (see Stem cells: excessive attempts lead to scandals).


This announcement, which has been welcomed by scientists and industrialists alike, has also been kept in perspective because “these treatments are still in their infancy”. Furthermore, clinical trials are still an essential part of the process.

Bionews, Marta Henriques (20/11/2017)

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