MHRA guidance for child safety
MHRA Guidance for Child Safety
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Price regulation and relative delays in generic drug adoption
Pharma Live, , Regulatory Affairs, 0
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A paradigm shift in Drug Regulatory in Taiwan!
Pharma Live, , Regulatory Affairs, 0
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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FDA Announces Major Proposed Rule Amending Hatch-Waxman Regulations – Courtesy (Hogan Lovells)
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On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed...
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Lipid excipients and delivery systems for pharmaceutical development: A regulatory perspective☆
Pharma Live, , Regulatory Affairs, 0
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Many fixed-dose drug combinations in India lack central regulatory approval – Courtesy (EurekAlert)
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Fixed-dose drug combinations (FDCs) which have not received central regulatory approval are sold in substantial numbers in India —...
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Drug Regulator Fixes Prices of 30 Formulation Packs in India – Courtesy (NDTV)
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The National Pharmaceutical Pricing Authority (NPPA) has fixed prices of 30 formulation packs, including drugs used to treat various...
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What Is the Industry Underestimating About An ADC Supply Chain? – Part 2 – Courtesy (pharmaceutical Online)
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In What Is the Industry Underestimating About An ADC Supply Chain? – Part 1, I spoke with industry experts from...
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Root Cause Analysis (RCA)
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Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of...
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