EN PL

News

FDA: Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment

17.09.2010
This guidance provides recommendations for the development of direct-acting antiviral agents (DAAs) regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration ...

EMA: Questions and answers on the review of the marketing authorisations for topical formulations of ketoprofen

10.09.2010
The European Medicines Agency has completed a review of the safety and effectiveness of ketoprofen-containing medicines used topically (on the skin). The Agency’s Committee for Medicinal ...

FDA: Guidance for Industry. Suicidality: Prospective Assessment of Occurrence in Clinical Trials

10.09.2010
The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products.2 Specifically, ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 11 Capillary Electrophoresis General Chapter

10.09.2010
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their ...

Polish Ministry of Health: Regulation project relating to the fees for issue of medical devices

02.09.2010
Regulation project relating to the fees for registration of medical devices, variations of medical devices and for the issue of other certificates. ...

Polish Ministry of Health: Regulation project relating to the method of submission of the medical devices

02.09.2010
Regulation project relating to the method of submission and information of the medical devices ...

Polish Ministry of Health: The project of the Act related to the change of the Pharmaceutical Law

02.09.2010
The project of the Act related to the change of the Pharmaceutical Law including changes in Art. 15 and Art. 16. ...

EMA: Herbal Medicinal Products: Valeriana/Humulus, Valerianae radix/Lupuli flos, Valeriana officinalis L. / Humulus lupulus L.

02.09.2010
Final community herbal monograph, opinion, assessment report, list of references, overview of comments on Valeriana officinalis L., radix and Humulus lupulus L., flos ...

MHRA: First draft of the consolidated medicines regulations

02.09.2010
The MHRA is undertaking a consolidation and review of medicines legislation. The aim of the project is to ensure that the legislative framework for medicines is comprehensive, comprehensible and ...

MHRA: Variations legislation 2010 - details of our experience to date, submissions audit and update to FAQs

02.09.2010
The new Variations Regulation (EC/1234/2008) took effect on 1 January 2010. This immediately applied to variations to marketing authorisations covered by European procedures. However, the MHRA has ...