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Regulatory considerations for vaccine development: talk 2 - clinical regulatory considerations 2

Part 2 of 2
Published on November 30, 2015   35 min

Other Talks in the Series: Vaccines

0:04
Okay, so what I'd like to turn now is to the three pathways available to actually getting a vaccine product license, that is, sending in a biological licensing application or BLA. The citations are given. The first one, 21 CFR 601 Subpart C is, for lack of a better term, called the traditional pathway, the standard pathway. Subpart E is the accelerated approval of biological products for serious or life-threatening illnesses. And Subpart H is relatively new, and this provides an opportunity to seek approval of biological products when human efficacy studies are not ethical or reasonable and this, dramatically, is called the "Animal Rule." I'll be going over all three of these.
1:03
So the traditional BLA pathway, again, Subpart C of 21 CFR 601 states that the key goals are to determine that the licensed biological products are safe, effective and not misbranded. The regulation sets standards for safety, effectiveness and labeling, which I will discuss, and requires adequate, well-controlled clinical trials for safety and efficacy assessments, as you've just seen I've discussed in the IND section. There's a strong preference for clinical disease endpoints that is preventing disease or preventing death as a result of the interventions but you'll see where there are some exceptions to this.
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Regulatory considerations for vaccine development: talk 2 - clinical regulatory considerations 2

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