Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients
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Frequently Asked Questions: Drug Master File Fee
Pharma Live, , Regulatory Affairs, 0
Q1. What DMFs incur fees? Only DMFs that cover the manufacture of an API (Type II API DMFs) for...
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Pharmaceutical industry regulation undermines NICE drugs appraisal work – Courtesy (Pharmanews.eu)
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Government policies that support UK pharmaceutical science and enhance export income are costing the NHS millions and undermine the...
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Markets for Pharmaceutical Products
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1-s2-0-b9780444535924000128-mainDownload
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What Is an Abbreviated New Drug Application, And What Does It Mean to Investors?
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Over the past year, a lot of investor attention has been focused on drugmakers as the industry increases its...
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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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Strides Arcolab gets US FDA approval for lamivudine & zidovudine tablets for HIV therapy – Courtesy(Pharmabiz)
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Strides Arcolab Limited has received approval from the United States Food & Drug Administration (FDA) for lamivudine and zidovudine...
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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...