Aktualności
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
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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
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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
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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This draft guidance provides a qualified context of use (COU) for the biomarker plasma fibrinogen, in interventional clinical trials of patients with chronic obstructive pulmonary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)
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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
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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
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EMA: Draft reflection paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus
02.07.2015
Hepatitis E virus (HEV) infection is widespread and blood/plasma donors are often asymptomatic. Therefore, there is a risk for viraemic blood donations. This raises questions about the safety of
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FDA: Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products
02.07.2015
This guidance has been developed to address the lack of clarity with respect to what chemistry, manufacturing, and controls (CMC) information in a marketing application constitutes an established
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FDA: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
02.07.2015
Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and
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RAPS: Indian API Manufacturer Faces Canadian Quarantine Over Data Integrity Issues
02.07.2015
Slovenian inspectors uncovered serious issues at Indian active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories, Health Canada has issued a voluntary quarantine for all products
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