Aktualności
FDA: Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen
13.08.2015
This guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription also
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RAPS: EMA Updates Two Pharmacovigilance Guidelines
13.08.2015
Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU.The two guidelines include a draft
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 4, 2015 concerning stimulating the development of medicines for children
13.08.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 4, 2015 concerning stimulating the development of
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 7, 2015 concerning the publication of updated guidelines on the labeling of packaging of medicinal products registered in
13.08.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 7, 2015 concerning the publication of updated
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EMA: Draft qualification opinion total kidney volume (TKV) as a prognostic biomarker for use in clinical trials evaluating patients with autosomal dominant polycystic kidney disease (ADPKD)
06.08.2015
The Critical Path Institute’s Polycystic Kidney Disease Outcome Consortium (PKDOC) intends to qualify Total Kidney Volume (TKV) as a prognostic biomarker (i.e. predictive for the outcome with
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EMA: Concept paper on the need for a single note for guidance on the chemistry of active substances
06.08.2015
This concept paper addresses the need to update and revise the guidance available on the chemistry of the active substance (new and existing active substances). There are currently two approved
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EMA: Concept paper on the revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant granulocyte-colony stimulating factor
06.08.2015
The current guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor (G-CSF) provides recommendations for the non-clinical and clinical development of
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FDA: Analytical Procedures and Methods Validation for Drugs and Biologics
06.08.2015
This guidance supersedes the draft of the same name that published on February 19, 2014 (79 FR 9467) and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods
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FDA: Request for Quality Metrics Guidance for Industry
06.08.2015
Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can
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GMP: Indian and Chinese API Manufacturers in the Focus of European Authorities
06.08.2015
The EudraGMP database was originally launched in April 2007 and is used to exchange information on compliance with the Good Manufacturing Practices (GMP) between the relevant regulatory
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