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Important Information: Medical Consultation Required: All prescription-based products require a consultation with a licensed provider, which may be conducted asynchronously (online evaluation) or synchronously (live telehealth appointment)

Volek J.S., Kraemer W.J., Rubin M.R

If scheduled, the meeting typically occurs 1 to 2 months before the approval decision date (called the PDUFA date)

During an open public hearing before the vote, the panel heard from multiple speakers, including public health advocates, physicians, and peptide companies, who expressed widely differing views on whether BPC-157 should be included on the 503A bulk drug list