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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 16, 2015 concerning the investigation by the European Medicines Agency safety profile of vaccines against human papilloma vi

16.07.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 16, 2015 concerning the investigation by the European ...

FDA: FDA approves new drug to treat heart failure

16.07.2015
The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death ...

REUTERS: Another Indian firm under fire for shoddy clinical trials work

16.07.2015
Another Indian clinical research organisation, Quest Life Sciences of Chennai, is in trouble over defective trials work, including manipulation of heart readings, according to a warning issued by ...

RAPS: FDA Finalizes Six-Month Drug Shortage Notice Regulation

16.07.2015
In 2011, after several years of worsening drug shortages, the Obama Administration issued Executive Order 13588 – Regarding Prescription Drug Shortages calling for measures to improve the ...

FDA: Testicular Toxicity: Evaluation During Drug Development

16.07.2015
The purpose of this guidance is to assist sponsors who are developing drug products that may have potential adverse effects on the testes, which we refer to as testicular toxicity, based on ...

FDA: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

09.07.2015
This guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current ...

FDA: DSCSA Implementation: Product Tracing Requirements for Dispensers

09.07.2015
This guidance addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C ...

FDA: Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease

09.07.2015
This draft guidance provides a qualified context of use (COU) for the biomarker plasma fibrinogen, in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) ...

GMP: Aseptic Manufacturing Operation: Chinese Company Zhuhai United Laboratories does not comply with EU GMP

09.07.2015
While the focus of attention has been on Indian manufacturers during the last 2 years now also Chinese manufacturers are again in the spot light. Just recently the EU found serious GMP deviations ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 9, 2015 concerning the publication of the Regulation of the Minister of Health of June 16, 2015 on the method of determinati

09.07.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 9, 2015 concerning the publication of the Regulation ...