Do cost-sharing and entry deregulation curb pharmaceutical innovation?
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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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Scottish cost regulators OK NHS use of 7 new drugs – Courtesy (Pharma Times)
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The Scottish Medicines Consortium has approved seven new medicines for use on NHS Scotland, including the first biologic treatment...
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FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Health Care Antiseptics
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The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety...
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Federal Circuit Says Regulatory Patent Term Extension Prolongs Life of Entire Patent – Courtesy(Pharma Patents)
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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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MOPI – Compliance with GMP for the Pharmaceutical Engineer
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Aim: To provide an introduction to the requirements of Good Manufacturing Practices for supporting design of facilities, equipment and...
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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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Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients
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1-s2-0-s1319016413000753-mainDownload
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Frequently Asked Questions: Drug Master File Fee
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Q1. What DMFs incur fees? Only DMFs that cover the manufacture of an API (Type II API DMFs) for...