Research Insights
A Glossary of FDA Compounding Terms: 503A, 503B, NPRM, Bulks List, DFO
A plain glossary of compounding regulatory terms you will see in Federal Register notices and PCAC coverage.
Oct 5, 2026
Read more →Research Insights & Peptide Science
Updates, guides, and science-backed content for the research community.
Quality & Testing
What "Research Use Only" Means in the U.S. Regulatory Framework
“Research Use Only” is a positioning and intended-use concept — not a magic label that overrides how a product is marketed or discussed.
Oct 5, 2026
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Quality & Testing
Why Consistent Substance Naming Matters for Identity and Reproducibility
Reproducible research depends on stable identity. When market names drift, literature, COAs, and regulatory records stop lining up.
Aug 13, 2026
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Quality & Testing
"Well-Characterized": What FDA Means When Assessing a Bulk Substance
In 503A reviews, “well-characterized” means FDA can reliably understand identity and composition. Inconsistent commercial naming undermines that foundation.
Aug 11, 2026
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Industry News
How FDA Public-Comment Dockets Work (and Why Deadlines Matter)
Federal Register notices open dockets with hard deadlines. Early comments are more likely to reach advisory committees; later comments may still inform FDA.
Aug 9, 2026
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Industry News
Why a PCAC "Yes" Vote Is Not FDA Approval
Advisory “yes” votes are recommendations. They are not drug approvals, not Category 1 listing, and not a finding that a substance meets the standards of an approved drug.
Aug 7, 2026
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