PatientSpotlight is built from primary sources. We do not rely on secondary coverage as a substitute for the underlying document. The categories below are the source types we routinely cite - they map directly to the sourceTypes tag on every piece.
Regulatory and reimbursement
- FDA approval letters, prescribing information, and post-marketing requirements
- FDA advisory committee transcripts and briefing documents across the relevant divisions
- CMS National Coverage Determinations and registry program documentation
- EMA scientific opinions, authorization decisions, and assessment reports
- NICE technology appraisals and final guidance documents
- MHRA authorizations and assessment summaries
- Other major-market regulators (PMDA, TGA, Health Canada) where relevant
Clinical and scientific
- Peer-reviewed publications of pivotal trials in the therapy area in question
- Major-conference proceedings, late-breaking sessions, and abstracts (ASCO, ASH, EULAR, ATS, ESC, AAIC, CTAD, ARVO and others, by therapy area)
- Consensus guidance from the relevant specialty societies and disease foundations
- Biomarker validation studies and assay technical documentation
- Imaging-modality validation literature relevant to the therapy area in question
- ClinicalTrials.gov and equivalent national registries
Industry and pipeline
- Sponsor pipeline disclosures, investor materials, and regulatory submissions
- SEC filings (10-Ks, 10-Qs, 8-Ks) for developers active in the therapy areas we cover
- Company-sponsored data presentations at the major specialty and investor conferences
- Manufacturing and supply-chain disclosures relevant to delivery infrastructure
Real-world evidence and health-system practice
- Published health-system rollout reports and protocol audits across the therapy areas we cover
- Specialty-lab reports on biomarker uptake and assay performance
- Registry data published or referenced in peer-reviewed venues
- Health-system imaging-capacity, infusion-capacity, and surgical-capacity disclosures
How sources appear in pieces
Every Signal, Insight, Snapshot, and Explained piece carries a "Key sources" section at the bottom. That section names the specific documents the piece relies on - the FDA label, the named NCD, the specific publication. The category-level tags at the top of the piece (for example, FDA · industry-filing · peer-reviewed) summarize the source mix without naming individual documents.
For more on how we use sources and what we will not do with them, see our Methodology and Editorial policy.