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RAPS: FDA Looks to Develop Regulatory Strategies for Genomic Testing

08.10.2015
To further the president\'s Precision Medicine Initiative (PMI), the US Food and Drug Administration (FDA) is working to develop regulatory systems for diagnostics using next generation sequencing ...

EMA: Draft qualification opinion on the ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials

21.09.2015
Proteus Digital Health Inc. intends to have its Proteus technology approved as a ‘qualified method’ for measuring adherence to medication in clinical trials by associating relevant physiologic ...

EMA: Draft concept paper on requirements for the production and control of allergen products for use in animals

21.09.2015
Recent developments require the revision of the existing CVMP/IWP Guideline on allergen products. Since the revision of this guideline in 1994, the scientific knowledge on structures, ...

EMA: Draft qualification opinion on the paediatric ulcerative colitis activity index (PUCAI)

21.09.2015
The paediatric ulcerative colitis activity index (PUCAI) measures disease activity in pediatric ulcerative colitis (Turner D. et al., 2007). It was developed to act as an accurate non-invasive ...

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. ...