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FDA: Hypertension Indication: Drug Labeling for Cardiovascular

23.03.2017
This guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling ...

EMA: Promoting high-quality clinical research in children through strengthened international collaboration

10.02.2017
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its ninth annual workshop on 16 May 2017 in London, UK. The aim of the workshop, that will take ...

RAPS: FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars

05.01.2017
Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on the initiation of the review on conducting research by the company Micro Therapeutic Research Labs in India

05.01.2017
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on the initiation of the review on ...

GMP: EMA issues new Guideline on "Chemistry of Active Substances"

05.01.2017
A medicinal product authorization application requires comprehensive information on origin and quality of an active substance. What information is required was defined in two Guidelines so far: ...

E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

07.12.2016
Pediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration of regulatory and scientific advances relevant to pediatric populations. This addendum ...

EMA: Revising the guideline on first-in-human clinical trials

17.11.2016
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human ...

RAPS: EMA Transparency: New Clinical Reports Go Live

17.11.2016
The European Medicines Agency (EMA) on Thursday kicked off its effort to proactively publish clinical trials data with the release of clinical reports for two drugs, Kyprolis and Zurampic, via a ...

EMA: Opening up clinical data on new medicines

25.10.2016
EMA provides public access to clinical reports As of today, the European Medicines Agency (EMA) gives open access to clinical reports for new medicines for human use authorised in the European ...

EMA: First comprehensive overview of global initiatives on medicine regulation published

20.10.2016
The European Medicines Agency (EMA) has published today an overview of existing international regulatory initiatives for human medicines. The mapping was carried out by EMA on behalf of the ...