Article archive

USP Draft of a newly proposed Chapter – <1115> Bioburden Control of Nonsterile Drug Substances and Products

17/10/2013 23:06
In the Pharmacopeial Forum 39(4), the USP published the draft of chapter <1115> "Bioburden Control of Nonsterile Drug Substances and Products". In their briefing, the USP outlined: "Microbial content in nonsterile products is controlled to a level consistent with patient safety. Use of...

U.S. Government Shutdown: Consequences for the FDA

17/10/2013 23:04
In the USA, Republicans and Democrats couldn't agree on a spending plan for the fiscal year 2014, which just started on 01 October. On September 17, 2013, the Office of Management and Budget (OMB) sent out a memo advising federal agencies to begin preparing for a government shutdown. On 01 October,...

Black Triangle: a New EU Requirement

17/10/2013 22:57
In the future, following an Implementing Regulation adopted by the European legislator, medicinal products with new APIs shall be subject to additional monitoring. This should help improve medicinal products safety (pharmacovigilance). The medicinal products in question should bear a warning...

FDA Guide on Import of Drugs prior to approval

17/10/2013 22:55
The U.S. Food and Drug Administration FDA has issued a draft guidance to define how the agency intends to deal with requests to import unapproved drug products. If a manufacturer anticipates approval and wants to prepare market launch, requests would be currently considered on a case by case...

Quality by Design: Lessons learnt from EMA/FDA Pilot Program

17/10/2013 22:46
In March 2011, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) launched a joined pilot program on Quality by Design (QbD) applications. The aim was to evaluate a possible parallel assessment by both agencies of certain quality/CMC sections which are relevant to...

EMA publishes Guideline on Pharmaceutical Development of Medicines for Paediatric Use

17/10/2013 22:42
The European Medicines Agency has published the final Guideline on pharmaceutical development of medicines for paediatric use. The date for coming into effect is 15 February 2014. On the 26th of January 2007, the "Paediatric Regulation" entered into force (Regulation EC No 1901/2006) with the aim...

New FDA Guidelines for Medical Devices

17/10/2013 22:38
Because of the number and complexity of medical devices, FDA's Center for Devices and Radiological Health (CDRH) has published many new guidelines. This makes it difficult to keep track of the current situation. In the following, we have compiled a selection of new FDA documents with regard to...

Successor Organisation (IMDRF) of the GHTF

17/10/2013 22:36
The International Medical Device Regulators Forum (IMDRF) has taken over the "old" the Global Harmonisation Task Force (GHTF) guidelines and plans to develop them further successively where necessary. First efforts have now been made. A current stand is available on the IMDRF website...

FDA Publishes Guidance on Clinical Trials

17/10/2013 22:32
At the beginning of August, the FDA released a guideline on monitoring of clinical trials. This document is the final version of a draft dated August 2011 in which a few comments have been integrated. The guideline includes for example more details about the performance of risk-based monitoring and...

EU-GMP Guide: final Chapter 2 on Personnel published

17/10/2013 22:28
The European Commission has published the revised Chapter 2 on Personnel, which will come into operation on 16 February 2014. Changes have been made in order to integrate the principles of "Pharmaceutical Quality System" as described in the ICH Q10 guideline. The basic principles of the chapter...
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