Published on: Mon, 29 Oct 2018 00:00:00 +0100
This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...
Europe - EFSA - European Food Safety Authority
The U.S. Food and Drug Administration announced in the Federal Register today the fiscal year 2019 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2018 (ADUFA IV) and Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III).
FDA - U.S. Food and Drug Administration
Among the topics covered in this issue of Danish Pharmacovigilance Update are: Maximum single dose of intravenous ondansetron (Zofran® and others) now restricted to 16 mg.
Danish Medicines Agency
The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.
Europe - EMA - European Medicines Agency