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to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new ...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

RAPS: FDA Revises Guidance on Special Protocol Assessments

11.05.2016
The draft guidance on the special protocol assessment (SPA) process is an update on guidance from 2002 and delves into the meetings between pharmaceutical or biotech sponsors and the US Food and ...

RAPS: EMA Finalizes Process Validation Guidance

11.05.2016
The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, ...

RAPS: Genomic Data and Drug Development: EMA Offers New Draft Guidance

11.05.2016
As the push for personalized medicine garners more attention, the European Medicines Agency (EMA) on Monday released new draft guidance to provide industry with more insight on how to identify and ...

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

11.05.2016
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: EMA publishes finalised Process Validation Guideline for Biotech Products

11.05.2016
Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been published under the title ...

GMP: New FDA Draft Guidance \'Data Integrity and Compliance with cGMP\' published

11.05.2016
In recent years, the topic \"data integrity\" has become a priority for European and American inspectors. At the beginning of 2015, the British authority MHRA published a first paper on that ...

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