Reference pricing, competition, and pharmaceutical expenditures: Theory and evidence from a natural experiment
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What Is an Abbreviated New Drug Application, And What Does It Mean to Investors?
Pharma Live, , Regulatory Affairs, 0
Over the past year, a lot of investor attention has been focused on drugmakers as the industry increases its...
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Regulation For Nutraceuticals in India – Courtesy(Pharmabiz.com)
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The Food Safety and Standards Authority of India, some time back, had set up a task force to put...
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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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ICH Guidelines Q1A – Q1F Stability
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The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in...
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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...
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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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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...