Drug & Device Details

Everything inside the drug and device detail panels — every section, what it contains, and where the data comes from.

Opening a detail panel

Click any drug or device — in the Drug & Devices tab, from a trial's Drugs & Devices badge, or from a chart — to open its detail panel. The panel pulls together regulatory, safety, commercial, and identifier data from many authoritative sources into one place. Sections that take longer to load are collapsible and fetch on demand when you expand them.

A header shows the name, source badge (FDA / EMA), approval date, and links out to the official record.
When a drug exists in both FDA and EMA, a selector lets you switch registries and see the approval-timing gap.
When a drug has several forms or routes, selectors let you switch between them.
A Raw Data button reveals the underlying structured data sheet for the item.

Drug panel — identity & chemistry

Section	What you'll find
Basic Info	Generic and brand names, common name, active ingredients, sponsor / marketing-authorisation holder, approval date.
Formulation	Dosage forms, strengths, and routes of administration.
Therapeutic Class	Therapeutic class, mechanism of action, and therapeutic-equivalence code.
GSRS Substance	Preferred name, substance class, molecular formula and weight, CAS / UNII / InChIKey / SMILES, plus targets & mechanisms and alternative names.
Cross-Registry Identifiers	UNII, RxNorm, ATC code(s), EU trial (EudraCT) and WHO registry IDs, each linking to the official source.

Drug panel — regulatory & exclusivity

Section	What you'll find
FDA / EMA Cross-Reference	The matching record in the other registry, with status, dates, holder, and approval-lag ("FDA first by 6 months").
Special Designations	Badges for orphan, fast-track, breakthrough, accelerated approval, priority review, REMS, biosimilar, generic, conditional approval, and more.
Orphan Designation	Designated indication, designation date, approval status, and exclusivity end date.
Exclusivity & Generic Entry	Exclusivity end date, first-generic-available date, and a key to the exclusivity-type codes (NCE, ODE, pediatric, biologic, …).
EMA Info	EU number, therapeutic area, ATC code, procedural route, holder country, and publication/revision dates.
FDA Regulatory Documents	Labels, approval letters, and reviews, grouped by type and linked to the source PDFs.

Drug panel — patents & biosimilars

Section	What you'll find
Patents / IP Cliff	A timeline of patent expirations colour-coded by urgency, with months remaining and links to each patent.
Adverse Events & Patents	A serious-event summary (deaths, hospitalizations, life-threatening, disabilities) and top reactions, alongside patent counts and earliest expiry.
Biosimilar & Purple Book	Reference-product / biosimilar status and the related biosimilars you can open individually.
Purple Book Patents	Listed patents with expiry dates and status (active / expiring soon / expired).
Related Approved Drugs	Sibling products that share the same active moiety — different forms, strengths, or sponsors — each openable on its own.

Drug panel — safety, label & commercial

Section	What you'll find
Active Drug Shortage	A banner with classification, reason, and posting date when the drug is currently in shortage.
Signal Detection (PRR/ROR)	Cross-trial safety signals: adverse event, organ system, and disproportionality scores (PRR and ROR) with a significance indicator.
FDA Label (DailyMed)	The boxed warning if present, plus indications, contraindications, adverse reactions, interactions, warnings, and dosing — expandable to full text.
NDC Products	Marketed product codes with names, ingredients, form/route, marketing dates, packaging, and labeler.
Commercial Intelligence	Acquisition cost (NADAC), Medicare Part B reimbursement (ASP), Medicare Part D spending with year-over-year change, and CMS Open Payments.

Device panel

The device panel is organized similarly, focused on submission, identifier, and safety data.

Section	What you'll find
Basic Info	Generic and trade names, applicant, product code, device class, and decision date.
Submission Info	Submission number and type, decision, advisory committee, and any supplement details.
Status Badges	Flags such as implant, life-sustaining, recall, expedited or third-party review.
Location	Manufacturer city, state, and country.
Classification Details	Medical specialty, regulation number, GMP-exempt status, and the classification definition.
Predicate Device	The predicate device a 510(k) was cleared against, when applicable.
GUDID Listing	Device identifier, manufacturer, MRI-safety status, latex status, sterilization, model/catalog numbers, dimensions, and manufacturer contact.
MAUDE Adverse Events	Reported events organized by closeness to the device — the exact device first, then same-manufacturer models, then others under the product code — with event types and narratives.
Signal Detection (PRR/ROR)	Disproportionality signals computed across devices under the product code.
Recall History	Recalls grouped by class (I / II / III) with reason, date, and recalling firm.
Manufacturing & Registration	Registered establishments — company, location, and establishment type.

Validation & provenance

Both panels are transparent about where data comes from and how confident a link is.

A validation badge shows whether a link is confirmed or still a suggestion, with the reasoning behind an automated assessment when available.
Source labels mark where each section's data originates — for example FDA, EMA, GSRS, DailyMed, FAERS, NADAC, Open Payments, Purple Book (drugs) and FDA, MAUDE, GUDID (devices).
A provenance line shows the data source and when it was last synced.
The Raw Data sheet exposes the full structured record if you want to inspect everything behind the panel.

Note: PRR and ROR are standard pharmacovigilance measures of whether an event is reported disproportionately often — higher values flag signals worth a closer look, not confirmed causation.