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Part of the approval process is ensuring there’s enough supply to support the intended use and, if there’s not enough, do a limited approval. That’s likely wha
by deelowe 5y ago
Part of the approval process is ensuring there’s enough supply to support the intended use and, if there’s not enough, do a limited approval.
That’s likely what’s going on here.
- s1artibartfast 5y agoIf you mean supply the population, this is not correct
- deelowe 5y agoMy understanding is that the FDA is considering limited authorization in cases where there's not enough to cover all individuals.
- s1artibartfast 5y agoI think that would be a first for the FDA, but I suppose it is possible. Normally they approve based solely on safety and risk/benefit. Sometimes products have limited approval for high risk groups, but for these reasons, not because of supply. Pricing and availability is not their job.