First In Line FDA Vs EMA Biopharma Approval Times
Drugs | News | Cambridge MedChem Consulting
Pharmaceutics | Free Full-Text | The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
Drugs approved by EMA in 2019 | News | Cambridge MedChem Consulting
2019 New Drug Approvals And Updates: The Year In Review
FDA Approves Four Biosimilars During Summer 2019 While Europe is on Vacation | Biosimilars Law Bulletin
Frontiers | Repurposing of Medicines in the EU: Launch of a Pilot Framework
An overview of cancer drugs approved through expedited approval programs and orphan medicine designation globally between 2011 and 2020 - ScienceDirect
Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA | SpringerLink
A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions | Journal of Medicinal Chemistry
EMA announces new medicine approval recommendations
PharmaBoardroom - EMA Drugs Approved in 2019
Numbers of FDA-approved and EMA-approved drugs indicated for... | Download Scientific Diagram
A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why
Summarising 2019: a year of firsts for the EMA
How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline (UPDATED) | Rothwell, Figg, Ernst & Manbeck, P.C. - JDSupra
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study | The BMJ
Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration | Journal of Law, Medicine & Ethics | Cambridge Core
European Medicines Agency - Wikipedia
2019 New Drug Approvals And Updates: The Year In Review
Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape - Mariya Gromova, Annegret Vaggelas, Gabriele Dallmann, Diane Seimetz, 2020
EMA adopts guideline on quality documentation for drug-device combination products | RAPS
Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia | JCO Oncology Practice
Biosimilars markets: US and EU compared - GaBI Journal
