The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
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Channel strategy and orphan drugs – Courtesy (PMLiVe)
Pharma Live, , Regulatory Affairs, 0
A channel strategy is a plan for guiding decisions about a product’s distribution channel, ie the chain of intermediaries...
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REGULATORY AFFAIR: LINK BETWEEN COMPANY AND GOVERNMENT AUTHORITY
Pharma Live, , Regulatory Affairs, 0
About Author:Yogeshkumar B. ViradiyaDepartment of Regulatory Affairs, Institute of Management Sciences and Research (IMSR),Nagpur, [email protected] Abstract:Regulatory affair is the...
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MHRA Guide for Labeling and Packaging
Pharma Live, , Regulatory Affairs, 0
MHRA guide for labeling and packaging
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Regulation of pharmaceutical prices: Evidence from a reference pricereform in Denmark
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1-s2-0-s0167629614000460-mainDownload
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FDA issues guidance to support the responsible development of nanotechnology products
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Three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory...
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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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Telmisartan: no double-dipping says CJEU, as it avoids answering all the questions – Courtesy (The SPC Blog)
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The Court of Justice of the European Union (CJEU) delivered its ruling in Case C‑577/13, Actavis Group PTC EHF, Actavis UK...
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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...