News
RAPS: India Unveils New Online Submission System for Clinical Trials
21.09.2015
India\'s Central Drugs Standards Control Organization (CDSCO) has launched a new online submission system for clinical trials as part of efforts to increase transparency, accountability and
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of September 18, 2015 concerning the implementation of the law those responsible for claiming a mystery enterprises within the meani
21.09.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of September 18, 2015 concerning the implementation of the
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RAPS: New FDA Guidance Addresses Common Issues in Orphan Drug Development
04.09.2015
The US Food and Drug Administration (FDA) has released a draft guidance intended to help drugmakers tackle common issues encountered in the development of drugs to treat rare diseases. ...
FDA: Uncomplicated Gonorrhea: Developing Drugs for Treatment
04.09.2015
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated gonorrhea. Specifically, this guidance addresses the Food and Drug
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GMP: Current FDA Publications for Medical Device Manufacturers
04.09.2015
In irregular intervals, the ECA publishes overviews of the FDA\'s new guidances or draft guidances, webinars, general strategy papers and inspection results concerning medical devices. The
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 20, 2015 concerning the interpretation of the term specified in the Ordinance of the Minister of Health of 5 November 2013
04.09.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 20, 2015 concerning the interpretation of the term
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FDA: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs
20.08.2015
This revised draft guidance provides recommendations on the disclosure of risk information in prescription drug product advertisements and promotional labeling in print media directed toward
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FDA: Rare Diseases: Common Issues in Drug Development
20.08.2015
This guidance assists sponsors of drug and biological products intended to treat or prevent rare diseases in conducting more efficient and successful development programs through a discussion of
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RAPS: Pakistani Manufacturers Shut Down in Protest Against Regulatory Amendment
20.08.2015
Members of the Pakistan Pharmaceutical Manufacturers Association (PPMA) have shut down their units in protest against regulatory changes. The actions were later postponed following the death of a
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EMA: Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 2)
20.08.2015
A post-authorisation safety study (PASS) is defined in Directive 2001/83/EC (DIR) Art 1(15) as any study relating to an authorised medicinal product conducted with the aim of identifying,
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