StemCell Therapy

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input theyre looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and its clear from the first round of posted responses that some of the top players including J&J and Pfizer would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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This entry was posted on October 25, 2020 at 5:58 am and is filed under Gene therapy. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |