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FDA enforcement discretion: why delaying serialization implementation is a risky strategy

In June 2017, the FDA announced that it will delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) for pharmaceutical manufacturers to November 2018 due to industry-wide concerns that many members of the pharmaceutical supply chain...

Influenza Is Nothing to Sneeze At

The Zika virus is considered a major global health risk, as infection during pregnancy is associated with babies born with microcephaly. The 2014 Ebola outbreak in West Africa killed over 11,300 people, despite not being spread...

Auditory Therapy, Ototoxicity and GLP Compliance Will the promising market for ear disorder treatments follow ophthalmologyโ€™s dramatic growth curve?

The numbers are daunting โ€“ 15% of the global population suffers from hearing loss, including a significant number of children, teenagers, and the elderly. Hearing loss presents a growing public health problem, due to ageing and an urban way...

Direct-to-Patient Solutions Assuring Patient Participation and Retention in Clinical Trials

The average cost of bringing a new drug to market is $2.6 billion, according to a 2014 report published by Tufts Center for the Study ofย Drug Development. This is a rise of 145%, adjusted for inflation, compared to just...

Asiaโ€™s increasing levels of clinical trial industry competition are to your benefit

Biotechnology and pharmaceuticalย companies within the United States andย Europe face an increasing number ofย hurdles when undertaking clinical trialsย within their own country or region;ย problems such as over saturated patientย pools, difficulties meeting andย maintaining enrollment numbers,ย increasing costs and lengthy time delays. While clinical trials...

Time for a Different Approach to Quality Systems in Biopharmaceutical Manufacturing

Despite the wide array of information systems available for biopharmaceutical manufacturing, we need to adopt a โ€œfollow-the-workflowโ€ approach to overcome the process inefficiencies generated by quality and production silos. For the better part of thirty years, a critical component of...

New centre is tackling manufacturing challenge of cell therapy field

Stem cell science has made huge progress since the early 1960s when Canadian researchers James Till and Ernest McCulloch discovered blood stem cells and advanced medical research across the globe. Today, the Alliance for Regenerative Medicine estimates there are more...

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