Aktualności
FDA: General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products - Draft
11.12.2014
This draft guidance is intended to assist those sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements to such applications who
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RAPS: EU Regulators Concerned About Drug Data Fraud by Indian Company
11.12.2014
European regulatory officials have expressed concern that dozens of medicines may have been approved in the EU based on fraudulent data conducted by a contract testing facility in Hyderabad, India. ...
URPL: nformation of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of December 10, 2014 concerning amendment of fees related to marketing authorization of a medicinal product since January 1, 2015.
11.12.2014
This document is an information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of December 10, 2014 concerning amendment of fees related
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EMA: Draft questions and answers on cyclodextrins in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use\'
04.12.2014
Following the European Commission decision to revise the Annex of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1), a
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EMA: Draft questions and answers on propylene glycol and esters in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’
04.12.2014
Following the European Commission decision to revise the Annex of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1), a
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GMP: Delegated Regulation on GMP for APIs published in the Official Journal of the EU
04.12.2014
On 25 November 2014, the \"Commission Delegated Regulation (EU) No 1252/2014\" was published in the Official Journal of the European Union. ...
EMA: Concept paper on revision of the addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacteriu
04.12.2014
This concept paper proposes a revision of the Committee for Medicinal Products for Human Use\'s (CHMP’s) addendum to the note for guidance on evaluation of medicinal products indicated for
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EMA: Questions and answers relating to open procurement procedure EMA/2014/48/PH - Monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance
04.12.2014
This document contains questions and answers relating to open procurement procedure EMA/2014/48/PH - Monitoring of scientific and medical literature and the entry of relevant information into
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EMA: Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
27.11.2014
This document aims to recommend an approach for deriving a scientifically based threshold value for individual active substances to be applied for risk identification. The guideline outlines how
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FDA: Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
27.11.2014
This guidance is intended for facilities planning to register or renew registration as human drug compounding outsourcing facilities (outsourcing facilities). This guidance describes the process
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