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REGULATORY AFFAIR: LINK BETWEEN COMPANY AND GOVERNMENT AUTHORITY
About Author:Yogeshkumar B. ViradiyaDepartment of Regulatory Affairs, Institute of Management Sciences and Research (IMSR),Nagpur, [email protected] Abstract:Regulatory affair is the...
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Federal Circuit Says Regulatory Patent Term Extension Prolongs Life of Entire Patent – Courtesy(Pharma Patents)
POSTED BY COURTENAY C. BRINCKERHOFF ON 3 NOVEMBER 2011POSTED IN FEDERAL CIRCUIT DECISIONS;PATENT TERM EXTENSIONI wrote previously about the patentability issues raised in Genetics Institute,...
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FDA awards $19m in rare disease grants – Courtesy ( PMLiVe)
The US FDA is to encourage research in rare diseases through 15 grants totalling more than $19m. The regulator...
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Regulatory Dark Horse? EU Directive on Cross-Border Patients’ Rights – Courtesy (pharmaexec.com)
The European Union’s directive on patients’ rights in cross-border healthcare was seen as a bit of a damp squib...
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Regulation of pharmaceutical prices: Evidence from a reference pricereform in Denmark
1-s2-0-s0167629614000460-mainDownload
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The moving parts of orphan drug development – Courtesy (PMLiVe)
The very mention of orphan drugs is enough to give some pharma accountants the jitters. Chasing a cure for...
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Regulatory Affairs: “Studty Report of New Drug Registration Process in European Union”
About Authors:Yogeshkumar B. Viradiya*, Manoj B. Dagwar, Swapnil T. LanjewarInstitute of Management Sciences and Research (IMSR),Nagpur, [email protected] Abstract:European Union...
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Comparision of NDA procedures & Regulatory structures in Turkey and Canada
About Authors:Abhisek Shukla*, Dr. Valluru RaviPharmaceutical Regulatory Affairs group, Dept. of Pharmaceutics,JSS College of Pharmacy, JSS University,Sri Shivarathreeshwara Nagar,...
