Lipid excipients and delivery systems for pharmaceutical development: A regulatory perspective☆
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FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Health Care Antiseptics
Pharma Live, , Regulatory Affairs, 0
The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety...
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Medical Writing Services in Asia: Recent Developments and Trends – Courtesy (PAREXEL)
Pharma Live, , Regulatory Affairs, 0
Authored by: Dr Julia Cooper, Vice President, Head of Global Medical Writing Services, PAREXEL In an increasingly complex and...
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The moving parts of orphan drug development – Courtesy (PMLiVe)
Pharma Live, , Regulatory Affairs, 0
The very mention of orphan drugs is enough to give some pharma accountants the jitters. Chasing a cure for...
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Drug Firms Warned Over Non-Registration With Online Database in India! – Courtesy (NDTV)
Pharma Live, , Regulatory Affairs, 0
With only 41 out of top 100 pharmaceutical firms responding to its direction to register for online database, the...
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Telmisartan: no double-dipping says CJEU, as it avoids answering all the questions – Courtesy (The SPC Blog)
Pharma Live, , Regulatory Affairs, 0
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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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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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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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)
Pharma Live, , Regulatory Affairs, 0
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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