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The traditional two-hit hypothesis has evolved into a more nuanced multiple-hit model, recognizing that these pathogenic drivers act in parallel and synergistically to impair hepatic function and promote disease progression

In every case where the committee voted yes, it did so against the written recommendation of FDA career staff, who had concluded after months of review that none of the seven substances met the agency's four-part evidentiary standard for inclusion on the 503A Bulk Drug Substances List

In summary, use the injections for as long as they are providing a clear benefit and need