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FDA: Nonclinical Evaluation of Endocrine-Related Drug Toxicity

21.09.2015
This guidance provides recommendations to sponsors of investigational new drug applications, new drug applications, and biologics license applications regulated by the Center for Drug Evaluation ...

FDA: Q3D Elemental Impurities

21.09.2015
Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present as impurities (e.g., through ...

GMP: FDA Guidance finalised: Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices

21.09.2015
In September 2014, we reported about the FDA guidance draft on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. Now, on 17 August, the FDA published the adopted ...

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 ...

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 ...

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The US Food and Drug Administration (FDA) has released a draft guidance intended to help drugmakers tackle common issues encountered in the development of drugs to treat rare diseases.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 ...

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 ...

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 ...

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 ...