Original Research
Accepted on 02 Feb 2026
Federating AI-Related Regulations for Human Therapeutics: An AI-Enabled, Continuously Updating Regulatory Intelligence System
Frontiers in Drug Safety and Regulation
- 259 views
101 Publications
volumes
Volume 6 - 2026
Volume 5 - 2025
Original Research
Published on 09 Jan 2026
Hepatobiliary adverse drug reactions during treatment with olaparib: an analysis of data from the EudraVigilance reporting system
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1736759
- 889 views
- 1 citation
Original Research
Published on 29 Dec 2025
Cohort event monitoring of booster COVID-19 vaccine safety using patient-reported outcomes in pregnant women
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1689349
- 1,652 views
Review
Published on 18 Dec 2025
A narrative review on the environmental impact of medicines: from water analysis and in vivo studies to prescribing appropriateness, based on European and Italian legal frameworks
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1681648
- 1,422 views
Mini Review
Published on 18 Dec 2025
Tokenization techniques for privacy-preserving healthcare data: tokenization nuts and bolts
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1599217
- 1,728 views
Review
Published on 17 Dec 2025
Pharmacovigilance and bioethics: the importance of a neglected relationship
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1698515
- 1,910 views
Case Report
Accepted on 15 Dec 2025
Dexamethasone-Induced Non-Hyperthyroid Hypokalemic Periodic Paralysis: A Case Report and Literature Review
Frontiers in Drug Safety and Regulation
- 344 views
Original Research
Published on 12 Dec 2025
A real-world disproportionality analysis of roflumilast using the US food and drug administration adverse event reporting system data
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1721656
- 1,299 views
Review
Published on 01 Dec 2025
The use of observed-to-expected analyses as a signal detection tool in COVID-19 vaccine safety surveillance: lessons learned from an industry perspective
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1650992
- 1,797 views
- 1 citation
Policy and Practice Reviews
Published on 01 Dec 2025
Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1651090
- 1,906 views
- 1 citation
Review
Published on 26 Nov 2025
Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a review
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1609455
- 1,635 views
Policy and Practice Reviews
Published on 26 Nov 2025
Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1648854
- 1,690 views
Perspective
Published on 25 Nov 2025
The role of MedDRA in global pharmacovigilance and public health during COVID-19: pandemic preparedness and response
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1607642
- 1,368 views
Original Research
Published on 14 Nov 2025
Reporting rates of abnormal uterine bleeding after COVID-19 vaccination in South Korea
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1658412
- 1,708 views
Correction
Published on 07 Nov 2025
Correction: Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1729828
- 1,156 views
Perspective
Published on 17 Oct 2025
Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1626822
- 4,823 views
Perspective
Published on 16 Oct 2025
Communicating medication risks in pregnancy: Towards shared decision making
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1712216
- 1,833 views
Opinion
Published on 16 Sep 2025
Rethinking drug safety signal detection and causality assessment in the age of AI: the risks of incomplete data and biased insights
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1678074
- 4,002 views
- 2 citations
Original Research
Published on 10 Sep 2025
Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1574430
- 2,438 views
Perspective
Published on 15 Aug 2025
A national pharmacovigilance centre perspective on pandemic preparedness - lessons learned from the COVID-19 pandemic
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1644680
- 4,328 views
- 1 citation
Clinical Trial
Published on 11 Aug 2025
Medication beliefs and adherence during and after pregnancy among women at risk for gestational hypertensive disorders
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1610273
- 2,509 views
Editorial
Published on 28 Jul 2025
Editorial: Safety of corticosteroids in respiratory medicine
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1656299
- 2,669 views
Review
Published on 20 Jun 2025
Centralized daily drug management in clinical trial institutions and specific implementation plans
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1620314
- 2,485 views
Methods
Published on 26 May 2025
Federated learning: a privacy-preserving approach to data-centric regulatory cooperation
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2025.1579922
- 7,120 views
- 1 citation