Question 1

What is pharmacovigilance intelligence?

Accepted Answer

Pharmacovigilance intelligence is research and monitoring of public safety data for drugs, biologics, and devices: adverse event reports, recalls, label safety changes, and regulator safety communications. Teams use it to watch their own products and competitors, prepare for safety questions, and see what regulators have published. It supports a pharmacovigilance system but does not replace one.

Question 2

Which safety sources does Assyro search?

Accepted Answer

Assyro searches the FDA Adverse Event Reporting System (FAERS), MAUDE device adverse events, FDA enforcement reports for drug, device, and food recalls, the FDA medical device recall database, FDA drug labels, DailyMed, and MHRA guidance, Drug Safety Update, and medical safety alerts. Published case reports come from PubMed and Europe PMC.

Question 3

Can I search the FDA adverse event database with Assyro?

Accepted Answer

Yes. Ask about a drug, biologic, or reaction and Assyro searches FAERS and cites the reports behind each answer. For devices, Assyro searches MAUDE. Adverse event counts are counts of reports, not incidence, and a report does not establish that the product caused the event.

Question 4

How do I search FDA recalls?

Accepted Answer

Ask about a product, company, or recall reason. Assyro searches FDA enforcement reports, which cover drug, device, and food recalls, and the FDA medical device recall database. Each recall in the answer is cited with its classification and the firm that recalled the product.

Question 5

Is Assyro a pharmacovigilance case processing system?

Accepted Answer

No. Assyro does not process individual case safety reports, run signal management under your PV system, or submit expedited or periodic safety reports to regulators. It is a research and monitoring tool for public safety data. Your safety database and procedures remain the system of record for case handling and reporting.

Question 6

Can FAERS data show how often a side effect happens?

Accepted Answer

No. FAERS collects spontaneous reports. Reports can be duplicated, incomplete, or influenced by publicity, and there is no count of how many patients took the drug. FAERS can show that a reaction has been reported, not how often it occurs or that the drug caused it.

Question 7

Can I get alerts when new adverse event reports or recalls appear?

Accepted Answer

Yes. Save a search on a product, ingredient, or company as a watch. Assyro checks it on the schedule you choose and emails you the records it has not shown you before, each linked to its source.

Question 8

Does safety intelligence cover medical devices?

Accepted Answer

Yes. For devices, Assyro searches MAUDE adverse event reports, the FDA medical device recall database, and device recalls in FDA enforcement reports. Cross-source profiles show one device type by FDA product code across every linked source.

See Adverse Event Reports and Recalls in One Search

Public Safety Data From Primary Sources

Drug and Device Adverse Event Reports

Recalls Across Drugs, Devices, and Food

Label Warnings and Safety Communications

Get an Email When New Safety Records Appear

Safety Research Your Team Can Verify

Research and Monitoring, Not Case Processing

One View Across Drugs, Devices, and Food

Guides for your next decision

Questions About Pharmacovigilance Intelligence

See Safety Intelligence on Your Own Products.