Results 31 to 40 of about 80,109 (188)

Third joint inter‐agency report on integrated analysis of consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from humans and food‐producing animals in the EU/EEA

EFSA Journal, 2021
The third joint inter‐agency report on integrated analysis of antimicrobial consumption (AMC) and the occurrence of antimicrobial resistance (AMR) in bacteria from humans and food‐producing animals (JIACRA) addressed data obtained by the Agencies' EU ...
European Centre for Disease Prevention and Control (ECDC), European Food Safety Authority (EFSA), European Medicines Agency (EMA)   +2 more
doaj   +1 more source

Clinical Study Reports published by the European Medicines Agency 2016-2018

, 2023
Clinical Study Reports published by the European Medicines Agency 2016 ...
Byrne, David
core   +1 more source

Application of real-time global media monitoring and ‘derived questions’ for enhancing communication by regulatory bodies: the case of human papillomavirus vaccines

BMC Medicine, 2017
Background The benefit-risk balance of vaccines is regularly debated by the public, but the utility of media monitoring for regulatory bodies is unclear.
Priya Bahri, Julianna Fogd, Daniel Morales, Xavier Kurz, on behalf of the ADVANCE consortium   +4 more
doaj   +1 more source

Enabling technologies driving drug research and development

Frontiers in Medicine, 2023
One of the strategic goals of the European Medicines Agency (EMA) and the European Medicines Regulatory Network is to support the research and uptake of innovative methods and technologies in the development of medicines.
Panna Vass, Dara Sevkan Akdag, Gabriel Enemark Broholm, Jesper Kjaer, Anthony J. Humphreys, Falk Ehmann   +5 more
doaj   +1 more source

The European Medicines Agency Experience With Pediatric Dose Selection [PDF]

The Journal of Clinical Pharmacology, 2021
AbstractGetting the right dose regimen for children and adolescents is important but poses great scientific, practical, and ethical challenges. At the same time, the availability of data in adults is a huge advantage and needs to be used optimally when designing studies in children and analyzing pediatric data.
Efthymios, Manolis, Flora T, Musuamba, Kristin E, Karlsson   +2 more
openaire   +2 more sources

PROTOCOL: Time to publication and characteristics of clinical data packages released by the European Medicines Agency under Policy 0070

, 2021
This is a protocol describing a study examining time to publication and characteristics of clinical data packages released by the European Medicines ...
Klaus Munkholm, Asger Sand Paludan-Müller   +1 more
core   +1 more source

The New European Medicines Agency Guideline on the Investigation of Bioequivalence [PDF]

Basic & Clinical Pharmacology & Toxicology, 2010
Abstract:  In this MiniReview, the main modifications made during the revision of the current Note for Guidance on the Investigation of Bioavailability and Bioequivalence are reviewed and justified. Several new features have been added to this guideline, as well as changes aimed at improving the clarity of the guidance provided.
Morais, José A. G., Lobato, Maria do Rosário   +1 more
openaire   +3 more sources

A European regulatory perspective on cystic fibrosis: current treatments, trends in drug development and translational challenges for CFTR modulators

European Respiratory Review, 2018
In this article we analyse the current authorised treatments and trends in early drug development for cystic fibrosis (CF) in the European Union for the time period 2000–2016.
Stefano Ponzano, Giulia Nigrelli, Laura Fregonese, Irmgard Eichler, Fabio Bertozzi, Tiziano Bandiera, Luis J.V. Galietta, Marisa Papaluca   +7 more
doaj   +1 more source

Information from Health Canada, Food and Drug Administration and European Medicines Agency used in the analysis of the drugs considered in this study.

, 2023
Information from Health Canada, Food and Drug Administration and European Medicines Agency used in the analysis of the drugs considered in this study.
Joel Lexchin (27840)
core   +1 more source

Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration

, 2021
Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of ...
Wallach, Joshua D., Kapczynski, Amy, Ross, Joseph S., Luxkaranayagam, Anita T., McCarthy, Margaret E., Herder, Matthew, Morten, Christopher J., Egilman, Alexander C.   +7 more
core   +2 more sources