MCA guide for safety quality and efficacy
MHRA Guide to Safety , Quality and Efficacy
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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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Drugs@FDA Frequently Asked Questions
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1. What is the purpose of Drugs@FDA, and what are its main uses? Drugs@FDA allows you to search for...
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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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FDA awards $19m in rare disease grants – Courtesy ( PMLiVe)
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The US FDA is to encourage research in rare diseases through 15 grants totalling more than $19m. The regulator...
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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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A REVIEW ON STABILITY GUIDELINES BY ICH AND USFDA GUIDELINES FOR NEW FORMULATION AND DOSAGE FORM
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ABSTRACTStability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and...
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Price regulation and relative delays in generic drug adoption
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1-s2-0-s0167629614000472-mainDownload
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Comparision of NDA procedures & Regulatory structures in Turkey and Canada
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About Authors:Abhisek Shukla*, Dr. Valluru RaviPharmaceutical Regulatory Affairs group, Dept. of Pharmaceutics,JSS College of Pharmacy, JSS University,Sri Shivarathreeshwara Nagar,...