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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 16, 2015 on on the malfunctioning analyzer INR used in the study ROCKET

17.02.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 16, 2015 on on the malfunctioning analyzer INR ...

EMA: Draft concept paper on guidance on statistical principles for clinical trials for immunological veterinary medicinal products

29.01.2016
A guideline on statistical principles for veterinary clinical trials for veterinary medicinal products (pharmaceuticals) (EMA/CVMP/EWP/81976/2010) was adopted in 2012. This guideline provides ...

EMA: First specific replacement therapy to treat rare bleeding disorder

29.01.2016
Coagadex recommended for approval for prevention of bleeding episodes for patients with factor X deficiency The European Medicines Agency (EMA) has recommended granting a marketing authorisation ...

RAPS: FDA Approves First Drug to Improve Overall Survival in Liposarcoma

29.01.2016
FDA Approves First Drug to Improve Overall Survival in Liposarcoma The US Food and Drug Administration (FDA) on Thursday approved a new indication for Eisai\'s Halaven (eribulin mesylate) to ...

RAPS: CFDA Begins Overseas Inspections

29.01.2016
CFDA Warns Indian, Japanese Manufacturers as Overseas Inspection Drive Begins China Food and Drug Administration (CFDA) has found fault with the manufacturing practices of four foreign ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 12, 2015 concerning the consequences of the loss of news tips published in the European Commission document,, Manual of D

29.01.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 12, 2015 concerning the consequences of the loss ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of December 28, 2015 concerning the new recommendations aimed at minimizing the risk of a rare infection PML, and one of the types

11.01.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of December 28, 2015 concerning the new recommendations aimed ...

FDA: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

11.01.2016
We, FDA, are providing you, establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations ...

FDA: Safety Assessment for IND Safety Reporting

11.01.2016
This document provides guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products2 developed ...

FDA: Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

11.01.2016
This guidance document provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with ...