Article archive

FDA will participate in a Medical Devices Single Audit Pilot Programme in 2014

14/12/2013 23:56
Earlier we reported about the activities of the successor organisation of the Global Harmonisation Task Force (GHTF): the International Medical Devices Regulators Forum (IMDRF). A working group of the IMDRF has been concentrating on a Medical Device Single Audit Program (MDSAP) and has elaborated...

New Developments in the EU with regard to Medical Devices

14/12/2013 23:53
After the "PIP scandal", the EU had announced a reform of the medical device regulation. Proposals were published in October 2012. Now, there are further developments. With the statement "Today the European Commission adopted two measures to improve the safety of medical devices fulfilling its...

FDA publishes Guidance for Industry on "Investigation Device Exemptions"

14/12/2013 23:50
On 1st October 2013, the FDA released the final version of the Guidance for Industry and FDA staff on "Investigation Device Exemptions (IDEs) for Early Feasibility Medical Devices Clinical Studies Including Certain First in Human (FIH) Studies". This is the final version of a draft from November...

Perspectives on the PQRI Extractables and Leachables "Safety Thresholds and Best Practices" Recommendations for Inhalation Drug Products

14/12/2013 23:46
The PDA Journal of Pharmaceutical Science and Technology September/October 2013 issue revisited the interesting topic of Leachables and Extractables Testing with three articles. The first article covers the history and development of the PQRI (Product Quality Research Institute's) and is entitled...

Revision of the EU GMP Guide: EU Commission Publishes Comments for Chapters 3, 5, 6 and 8

14/12/2013 23:44
On 17 January 2013, the EU Commission published the drafts of 4 revised chapters of the EU GMP Guide. Responses to the public consultation have now been published on the EU Commission website. What were the major changes? Paragraph 6 of Chapter 3 Premise and Equipment has been revised and extended....

Guidelines on GDP (EU) revised

14/12/2013 23:42
Only eight months after their publication, the Guidelines from 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use have been revised. But those who were hoping for major changes and possible less stringent regulations will be disappointed. The new version corrects factual...

Risk Assessment for ascertaining GMP for Excipients

14/12/2013 23:37
The EU has published the comments received from the industry regarding the publication of the draft guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. This document was published by EU...

Torrent buys Elder's domestic business, keeping it Indian controlled

14/12/2013 21:11
India's Elder Pharmaceuticals, which a host of Western drugmakers were rumored to be interested in, will remain Indian owned. Torrent Pharmaceuticals will acquire the domestic business of Elder, relieving its debt situation and satisfying critics of growing foreign ownership of Indian...

My new Mobile Application "SRK GMP FAQ"

14/12/2013 14:18
Hi Friends!   We get some questions related to GMP (Good Manufacturing Practices) frequently. Some of us know how and where to get answers for those. But still many people are there among us who need support to find answers. So I want to provide support to them by this application. Through...

Updates on Medical Device Regulations

14/12/2013 00:02
In irregular intervals, the team of CONCEPT HEIDELBERG publishes overviews over new FDA's Guidelines or Draft Guidelines regarding medical devices. In the following, you will find a selection from August/ September/ October . The draft of a "Question and Answer document" (entitled "The...
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