Brief · Use case · Pharmacovigilance
Class Safety Communication Scan.
LiveScanTake stock of FDA and EMA safety communications and label changes for a drug class in two years, with the boundary and borderline items named.
Class Safety Communication Scan is a ready-made use case for Pharmacovigilance. It ships under the Scan template.
For pharmacovigilance and medical safety leads. You get the scope rule and method first, each communication with its issuer, category and maturity, how the field divides and what was not covered. Items are cited to the authority or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
Which regulatory safety communications and label changes have the FDA and the EMA issued for a named drug class in the last twenty-four months?
What is scanned
Each regulator communicates safety in its own way. The scan lists each communication as the kind of document it is, so a US safety communication is not read as an EU recommendation.
| Source | What it holds | What the scan does with it |
|---|---|---|
| FDA Drug Safety Communications | Communications that alert patients and health professionals to new safety issues with medicines, which FDA may issue after reviewing trial data, case reports or the literature. FDA lists them chronologically, newest first, on one page.1 | Lists each communication in the class with its date and title, and notes where it came with a label change. |
| EMA PRAC outputs | The Pharmacovigilance Risk Assessment Committee assesses and monitors the safety of human medicines and publishes meeting highlights after each plenary, together with agendas and minutes.2 | Lists the committee’s recommendations that concern the class, taken from the highlights, agendas and minutes. |
| Label changes | Changes to prescribing information and product information that follow a communication or a recommendation.1,2 | Listed as linked rows where a source ties them to a communication, and as separate rows where it does not. |
What the scan does
Communications as documents. A US drug safety communication and an EU committee recommendation are different documents with different standing. The scan names the document type for every item and the body that issued it.1,2
Where the sources are silent. FDA’s page lists communications but does not describe filtering by class, and the PRAC page lists highlights, agendas and minutes but does not itself describe a signal list. The scan says which parts of its search relied on reading those documents one by one.1,2
Class edges. The scan names the class and the substances in it before searching, and lists a borderline substance separately.
How it was run. The Comprehensive scan reports each source, the date, the terms and how many communications it found against how many it kept.
Recommended length
Comprehensive
Two regulators are searched over two years and completeness matters, so the method has to be auditable. Comprehensive adds the account of how the scan was run and what stands out.
You can pick another length on the form. The other two stay available.
Assumptions the scan checks
The scan states the assumptions its boundary and its sources rest on, and the closing section says what they leave out. Examples for this subject:
- The class is defined by a list of substances the scan states.
- Every communication relevant to the class appears on the regulators’ public pages.
- A label change is dated by the regulator’s decision and not by the date of a company’s update.
Standards, guidance and sources
Regulators’ own pages
The decision practice behind the memo itself is on the template page.
What gets flagged
Any communication that only one regulator issued, any label change that the scan could not tie to a communication, and any part of the search that relied on reading documents one by one.
What arrives
- Scope and boundary
- How the scan was run
- What is out there
- How the field divides
- What stands out
- What this does not cover
What it will not do
It does not rank or score the items it finds, and it does not recommend one. A scan lists what exists; when you need a view on it, run a Comparison or a Decision Memo on the items you choose.
It does not assess whether a safety signal is real or whether a communication was justified, and it is not a pharmacovigilance assessment.
It does not rank or score the items. A scan says what exists; it does not say which item is preferable.
It is a snapshot of one date. It does not monitor the field after that date.
It lists what it could find in the sources it names. Items in sources it could not open are listed as not covered.
References
- [1] U.S. Food and Drug Administration. Drug Safety Communications. Content current as of 15 September 2026. Read on 9 October 2026.
- [2] European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC). Read on 9 October 2026.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
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