Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

Debunking mRNA Vaccine Misconceptions—An Overview for Medical Professionals

(2021) Frederick L. Hitti et al.   AMERICAN JOURNAL OF MEDICINE

The Relationship between US Adults’ Misconceptions about COVID-19 Vaccines and Vaccination Preferences

(2021) Sarah E. Kreps et al.   Vaccines

Forty days of regulatory emergency use authorisation of COVID-19 vaccines: Interfacing efficacy, hesitancy and SDG target 3.8

(2021) Godwell Nhamo et al.   Global Public Health

Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study

(2020) Thomas J Hwang et al.   BMJ-British Medical Journal

To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

(2019) Thomas Christian Kühler et al.   BMJ Open

Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval

(2019) Roberta Joppi et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Changing standards for drug approval: A longitudinal analysis of conditional marketing authorisation in the European Union

(2018) Jarno Hoekman et al.   SOCIAL SCIENCE & MEDICINE

FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines

(2017) Lawrence Liberti et al.   Frontiers in Pharmacology

Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006–2015: a cohort study

(2016) Denis Boucaud-Maitre et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?

(2015) Saad Alqahtani et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine

(2015) Lada Leyens et al.   Public Health Genomics

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

(2015) Aaron S Kesselheim et al.   BMJ-British Medical Journal

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

(2015) Aaron S Kesselheim et al.   BMJ-British Medical Journal

FDA Designations for Therapeutics and Their Impact on Drug Development and Regulatory Review Outcomes

(2015) AS Kesselheim et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies

(2015) Brooke Courtney et al.   JOURNAL OF LAW MEDICINE & ETHICS

Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

(2014) Nicholas S. Downing et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

A Review of Regulatory Mechanisms Used by the WHO, EU, and US to Facilitate Access to Quality Medicinal Products in Developing Countries With Constrained Regulatory Capacities

(2013) Yauba Saidu et al.   Therapeutic Innovation & Regulatory Science

Assessing the Performance of the EMEA's Centralized Procedure: A Comparative Analysis with the US FDA

(2012) Laura B. Faden et al.   DRUG INFORMATION JOURNAL

Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe

(2010) W P C Boon et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS