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FDA: Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification

09.06.2016
This guidance is intended to assist submitters of a biomarker for qualification that conduct nonclinical studies for which histopathology is used as a reference or truth standard (Zhou et al. ...

FDA: Use of Electronic Health Record Data in Clinical Investigations

09.06.2016
This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic ...

GMP: EMA\'s new Draft Guideline on the Sterilisation of Medicinal Products, APIs, Excipients and Primary Containers

09.06.2016
As referred to in the European Pharmacopoeia, the procedure for terminal sterilisation of a medicinal product, an API, or an excipient is generally the method of choice. Yet, this might be ...

GMP: FDA´s new policy regarding grouping of supplements for CMC changes

09.06.2016
On April 19, 2016 the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) released a new document outlining how supplements can be grouped together and submitted ...

GMP: EMA publishes QPPV Update

09.06.2016
In April 2016 the European Medicines Agency (EMA) published the first issue of the quarterly issued \"QPPV Update - What´s new in Pharmacovigilance\". The \"QPPV Update\" replaces the ...

EMA: Current European Non-Compliance Report for an Indian API Manufacturer

09.06.2016
Major deficiencies observed during GMP inspections are entered into the EudraGMDP database. There, you can find a current Non-Compliance Report issued by the Italian Medicines Agency for the ...

RAPS: FDA Amends Regulations on General Biologic Standards for First Time Since 1977

11.05.2016
The revisions to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new ...

FDA: Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral

11.05.2016
The purpose of this guidance is to assist sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C (CHC) from the preinvestigational new ...

EMA: Draft information in the package leaflet for fragrances containing allergens in the context of the revision of the guideline on \'Excipients in the label and package leaflet of medicinal products for human use\' (CPMP/463/00 Rev. 1)

11.05.2016
This document supports the revision of the European Commission Guideline on \'Excipients in the label and package leaflet of medicinal products for human use\' with regard to fragrance allergens. ...

EMA: Draft guideline on good pharmacogenomic practice

11.05.2016
The aim of this guideline is to lay out the requirements related to the choice of appropriate genomic methodologies during the development and life-cycle of a drug. ...