Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape - Mariya Gromova, Annegret Vaggelas, Gabriele Dallmann, Diane Seimetz, 2020
Human medicines: highlights of 2019 | European Medicines Agency
A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions | Journal of Medicinal Chemistry
FDA Approves Four Biosimilars During Summer 2019 While Europe is on Vacation | Biosimilars Law Bulletin
Numbers of FDA-approved and EMA-approved drugs indicated for... | Download Scientific Diagram
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study | The BMJ
An overview of cancer drugs approved through expedited approval programs and orphan medicine designation globally between 2011 and 2020 - ScienceDirect
A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions | Journal of Medicinal Chemistry
EMA adopts guideline on quality documentation for drug-device combination products | RAPS
ANNUAL REPORT 2019 | European Medicines Agency
Drugs approved by EMA in 2019 | News | Cambridge MedChem Consulting
Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia | JCO Oncology Practice
EU agency recommends 66 drugs in 2019, lowest in 5 years | S&P Global Market Intelligence
FDA Approves Four Biosimilars During Summer 2019 While Europe is on Vacation | Biosimilars Law Bulletin
Compare FDA guidance to EMA & PMDA for in vitro DDI assessments
Biosimilars approved by the European Medicines Agency (EMA) and the US... | Download Table
Pharmaceutics | Free Full-Text | The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
Summarising 2019: a year of firsts for the EMA
Frontiers | Repurposing of Medicines in the EU: Launch of a Pilot Framework
2019 New Drug Approvals And Updates: The Year In Review
From labs to shelves: EMA's new booklet explains how drugs are developed and marketed in the EU – TIF
Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA | SpringerLink
2019 New Drug Approvals And Updates: The Year In Review
