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EMA: Scientific guideline: Concept paper on the need for the guidance on the clinical investigation of medicinal products to slow progression of renal insufficiency

24.09.2010
Renal insufficiency and end-stage renal disease has a major impact on public health and several medicinal compounds have been licensed or are under development with the aim to halt or slow renal ...

EMA: Scientific guideline: Guideline on missing data in confirmatory clinical trials

24.09.2010
This guideline provides advice on how the presence of missing data in confirmatory clinical trials should be addressed and reported in a dossier submitted for regulatory review and provides an ...

MHRA: Braille on packaging for medicinal products

24.09.2010
The British Standards Institute has recently published BS EN 15823:2010 Packaging. Braille on the packaging of medicinal products. This specifies the requirements and provides guidance for the ...

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. ...

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