Skilskis on Cursor

distinguish prea (mandatory) from bpca (voluntary) pediatric drug development obligations — psps, pediatric assessments, deferrals, waivers, written requests, 6-month exclusivity. self-contained — no external lookups required.

audit prescription drug marketing act (pdma) and dscsa compliance for prescription drug sample distribution under 21 usc §353(c)/(d), 21 cfr part 203, sample reconciliation, healthcare practitioner sample requests, distributor licensing. self-contained — no external lookups required.

construct or analyze an fda risk evaluation and mitigation strategy (rems) under 21 usc §355-1 — medication guides, communication plans, elements to assure safe use (etasu), implementation systems, assessment timetables, rems shared system, rems modifications. self-contained — no external lookups required.

construct an fda form 483 / warning letter response protocol — iom-mapped 15-business-day clock for 483, 15-day clock for wl acknowledgment, root cause + corrective action + preventive action, repeat-observation analysis, untitled letter and seizure/injunction risk. self-contained — no external lookups required.