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EMA: EMA Procedural advice for users of the centralised procedure for generic/hybrid applications

15.09.2011
This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the ...

EMA: Standard operating procedure for preparation of the public summary of opinion for orphan medicinal product designation.

06.09.2011
This SOP describes the preparation and publication of public summaries of opinion following positive and negative opinions by the Committee for Orphan Medicinal Products on applications for ...

FDA: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring.

06.09.2011
This guidance is intended to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human ...

FDA: Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation.

06.09.2011
This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met to facilitate the ...

EMA: Standard operating procedure for handling of standard requests for data analysis.

06.09.2011
This document describes the process which is followed by members of the Section for Signal Detection and Data Analysis (P-PV-SDA) in situations when a standard request for data analysis, i.e. ...

Polish Office for Registration: New version of the validation criteria for electronic applications for human medicines.

06.09.2011
Message from the President of the Office for Registration of 30.08.2011 on the revision of the validation criteria for electronic application for human medicines product. ...

FDA: Standards for Clinical Trial Imaging Endpoints.

06.09.2011
The purpose of this guidance is to assist sponsors in the use of endpoints that depend on the results of imaging tests in clinical trials of therapeutic drugs and biological products.2 This ...

EMA: New validation criteria for electronic submissions

29.08.2011
The European Medicines Agency is informing pharmaceutical companies that a new version of the validation criteria for electronic applications for human medicines is coming into effect on Thursday ...

FDA: Documentation (510 k) of Medical Device Modifications

29.08.2011
FDA published a draft on the documentation of medical device modifications. This draft guidance for industry and FDA staff is entitled \"510 (k) Device Modifications: Deciding When to Submit a 510 ...

EUCOMED: The Appropriateness of Evidence and the Learning Curves for Medical Devices in Europe

29.08.2011
Supplement Paper to the Eucomed Position paper on Health Technology Assessment (Siebert et al, 2002) Aiming to Clarify two Important Topics that were already partly Addressed in the First Paper: ...

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