Lipid excipients and delivery systems for pharmaceutical development: A regulatory perspective☆
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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 $19m. The regulator...
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Global Specialty Enzymes Industry 2015
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NEW YORK, June 4, 2015 /PRNewswire/ — This report analyzes the worldwide markets for Specialty Enzymes in US$ Million...
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US FDA issues draft norms on waiver of in-vivo BA & BE studies for subsequent analysis; pharma cos to save time, cost – Courtesy(Pharmabiz.com)
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The US FDA has issued draft guidelines on waiver of in-vivo bioavailability (BA) and bioequivalence(BE) studies for immediate release...
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Regulation of pharmaceutical prices: Evidence from a reference pricereform in Denmark
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1-s2-0-s0167629614000460-mainDownload
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A paradigm shift in Drug Regulatory in Taiwan!
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About Authors:*Parasiya Sachin kumar R., Balamuralidhara V., Pramod Kumar T.M., Rohit Gujarati, Abhisek Shukla, Vandana KshatriPharmaceutical Regulatory Affairs Group,...
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European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections
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The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share...
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What Is an Abbreviated New Drug Application, And What Does It Mean to Investors?
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Over the past year, a lot of investor attention has been focused on drugmakers as the industry increases its...