Regulation of pharmaceutical prices: Evidence from a reference pricereform in Denmark
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EMA and US FDA release first conclusions of parallel assessment of quality-by-design applications
Pharma Live, , Regulatory Affairs, 0
The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint...
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Comparision of NDA procedures & Regulatory structures in Turkey and Canada
Pharma Live, , Regulatory Affairs, 0
About Authors:Abhisek Shukla*, Dr. Valluru RaviPharmaceutical Regulatory Affairs group, Dept. of Pharmaceutics,JSS College of Pharmacy, JSS University,Sri Shivarathreeshwara Nagar,...
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FDA awards $19m in rare disease grants – Courtesy ( PMLiVe)
Pharma Live, , Regulatory Affairs, 0
The US FDA is to encourage research in rare diseases through 15 grants totalling more than $19m. The regulator...
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What Is the Industry Underestimating About An ADC Supply Chain? – Part 2 – Courtesy (pharmaceutical Online)
Pharma Live, , Regulatory Affairs, 0
In What Is the Industry Underestimating About An ADC Supply Chain? – Part 1, I spoke with industry experts from...
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Channel strategy and orphan drugs – Courtesy (PMLiVe)
Pharma Live, , Regulatory Affairs, 0
A channel strategy is a plan for guiding decisions about a product’s distribution channel, ie the chain of intermediaries...
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Root Cause Analysis (RCA)
Pharma Live, , Regulatory Affairs, 0
Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of...
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Indian Pharmacy Practise Regulations 2015 – Courtesy(Pharmabiz.com)
Pharma Live, , Regulatory Affairs, 0
The government of India last January issued a notification entitled Pharmacy Practice Regulations 2015 aimed at enhancing the status...
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