Monitored Sources
The international regulatory agencies from which we collect and curate news every day.
U.S. Food & Drug Administration
United States of America
The FDA is the U.S. federal agency responsible for regulating drugs, medical devices, biological products, and food. We specifically monitor the Press Announcements section of the FDA Newsroom, which publishes communications about:
- New drug approvals and authorizations
- Safety alerts and product recalls
- Generic drug and biosimilar updates
- Relevant regulatory guidelines and decisions
We also track FDA Guidance Documents, which outline the agency's current thinking on regulatory and scientific topics, and the FAERS (FDA Adverse Event Reporting System) database, one of the world's largest repositories of post-marketing safety data.
European Medicines Agency
European Union
The EMA is the European Union agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines. We monitor the News section with a focus on the Pharmacovigilance category, which includes:
- PRAC (Pharmacovigilance Risk Assessment Committee) recommendations
- Marketing authorization reviews and updates
- Safety signals and new adverse effects
- European regulatory procedure updates
Key EMA resources we reference include EPARs (European Public Assessment Reports) — publicly available documents detailing the scientific evaluation of centrally authorised medicines — and EudraVigilance, the EU database of suspected adverse drug reaction reports.
Medicines and Healthcare products Regulatory Agency
United Kingdom
The MHRA is the UK's regulatory agency for medicines and medical devices. Following Brexit, it assumed an autonomous role in pharmaceutical regulation. We monitor official communications covering:
- Safety alerts and medicine updates
- New authorizations and regulatory decisions
- Drug Safety Updates and healthcare professional communications
- Post-Brexit guidelines and orientations
The MHRA's Drug Safety Update is a monthly newsletter for healthcare professionals containing the latest safety advice, including updates on the Yellow Card scheme — the UK system for reporting suspected adverse drug reactions.
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