PMR: Non-pharmacy market of OTC products in Poland in 2011-2013

In 2009 the non-pharmacy market of OTC products (comprising medicines and dietary supplements) rose by around 11% year on year and exceeded PLN 1bn (€231m) for the first time on record. The year ...

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

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.

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.

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.

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.

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.

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.

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

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

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 ...

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