Article archive

Complimentary Life Sciences Guidebook: Best Practices for FDA Compliance software solutions

18/06/2014 23:26
Selecting, Implementing, and Using FDA Compliance Software Solutions:THE LIFE SCIENCES GUIDEBOOK This guidebook provides you with a basic overview for selecting, implementing and using FDA Compliance and Quality Management solutions. Learn the importance of QMS, best practices for FDA...

Class 2 Medicines Recall (action within 48 hours): Clarithromycin 500mg Powder for Solution for Infusion in Agila livery manufactured Strides Arcolab International Limited (EL (14)A/07)

18/06/2014 23:09
  Class 2 Medicines Recall (action within 48 hours): Clarithromycin 500mg Powder for Solution for Infusion in Agila livery manufactured Strides Arcolab International Limited (EL (14)A/07)   Source: MHRA

Fake Antibiotics Feed Growing Worldwide Superbugs Threat

18/06/2014 23:05
Antibiotics now rank among the most counterfeited medicines in the world, feeding a global epidemic of drug-resistant superbugs.   Read more  

Adverse drug reactions e-modules

18/06/2014 23:01
NHS Education for Scotland (NES) in conjunction with the Yellow Card Centre Scotland has launched six new e-learning modules to support healthcare professionals in identifying and reporting Adverse Drug Reactions (ADRs). Adverse Drug Reactions e-Modules (external link)   To access the...

Death by prescription painkiller

18/06/2014 22:36
The number of deaths involving commonly prescribed painkillers is higher than the number of deaths by overdose from heroin and cocaine combined, according to researchers at McGill University. In a first-of-its-kind review of existing research, the McGill team has put the spotlight on a major public...

Medical Device News: Microwave Helmet 'Can Spot a Stroke'

18/06/2014 22:15
Scientists say they have devised a helmet that can quickly determine whether a patient has had a stroke. It could speed diagnosis and treatment of stroke to boost chances of recovery, the scientists say. BBC  

India's Data Integrity Problems

18/06/2014 22:13
In recent months, the US Food and Drug Administration (FDA) has identified nearly a dozen Indian pharmaceutical manufacturers who have had problems with the data integrity practices at their respective facilities. Those data are intended to ensure that products meet pre-established specifications,...

Guidelines on requirements and expectations for the qualified person in a pharmaceutical company by DHMA

18/06/2014 21:33
The Danish Health and Medicines Authority (DHMA) has published a document which shows that the EU has left enough leeway for the implementation of EU directives. This could be an option in other EU Member States to prevent the threatening shortage of QPs (Qualified Persons).  EU Directive...

HMPC Q&A Documents on Herbal Medicinal Products

18/06/2014 21:30
EMA's HMPC (Committee on Herbal Medicinal Products) published the Questions & Answers document on (traditional) herbal medicinal products. The document also addresses herbal medicinal products which don't have a European tradition. The Q&A document contains Questions & Answers about the...

Regulators Again Find Data Integrity Problems at Indian Manufacturing Site

18/06/2014 21:20
  Regulators Again Find Data Integrity Problems at Indian Manufacturing SiteBy Alexander Gaffney, RAC 
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