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RESEARCH INTELLIGENCE / 04

A clearer view of
what is changing.

Primary-source updates, research-policy signals, and transparently labeled FDA decision data. Our goal is context—not headline noise.

✳
A WEEKLY
RESEARCH SIGNAL.
THE WEEKLY SIGNALChecking source updates…
SOURCES & DEVELOPMENTS

Research at the source.

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REGULATORY DATA / FDA

What is receiving FDA decisions?

Different regulatory pathways are displayed separately. The counts are not comparable across drug and medical-device datasets.

DRUGS · CDER

Novel drug approvals by year

FDA
Current year-to-date totals are not displayed. Source: FDA CDER novel drug approval annual listings. This excludes many other approval categories.
OPEN FDA PRIMARY DATA ↗
DEVICES · 510(k)

Clearance decisions vs non-equivalence

openFDA
Requesting current openFDA decision totals…
510(k) substantially equivalent (SE) decisions are clearances; not substantially equivalent (NSE) decisions are not clearances. These are not PMA approvals/denials. Monthly source updates; counts may lag.
OPEN DEVICE DATA DOCUMENTATION ↗
A complete-response letter, withdrawn application, or request for additional data should not automatically be labeled a regulatory denial. Public cross-category “approval vs denial” totals are not methodologically sound without specified cohorts and definitions.
REGULATORY LESSONS / 2026

Recent setbacks.
Useful clinical lessons.

FDA complete-response letters and EMA negative opinions often expose hard questions about endpoints, effect estimates, evidence robustness and interpretation. Examine selected public cases, their documented status and the analytical disciplines involved.

Review regulatory case studies ↗
FDA · JUL / OCT 2026OrviglanceClinical evidence & endpoint strategy
EMA · SEP 2026XervytegBenefit–risk & evidence limitations
EMA · JUL 2026QezzaqarRobustness & treatment comparisons
REFERENCE DESK

Go straight to the source.

FDANovel Drug ApprovalsYear-by-year FDA CDER decisions↗FDAMedical Device 510(k)Public decision records and searchable fields↗NIHNIH News ReleasesInstitutional research announcements↗NLMClinicalTrials.govRegistered clinical studies and results↗EMAEuropean Medicines AgencyEU regulatory news and scientific guidance↗SASSAS Statistical InsightsTechnical programming and analytics perspectives↗
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