Markets for Pharmaceutical Products
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Janssen’s Fruitful Continuous Manufacturing Collaboration
Pharma Live, , Regulatory Affairs, 0
Janssen Supply Chain, part of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), has a long-standing collaborative partnership...
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MOPI – Good (Quality Control) Laboratory Practices (G(QC)LPs)
Pharma Live, , Regulatory Affairs, 0
Aim: To facilitate the development of knowledge, and expertise in the regulations, quality standards and guidelines that govern the...
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Many fixed-dose drug combinations in India lack central regulatory approval – Courtesy (EurekAlert)
Pharma Live, , Regulatory Affairs, 0
Fixed-dose drug combinations (FDCs) which have not received central regulatory approval are sold in substantial numbers in India —...
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Formulation factors affecting acceptability of oral medicines in children – ScienceDirect
Pharma Live, , Regulatory Affairs, 0
Acceptability of medicines in children and caregivers affects safety and effectiveness of medicinal treatments. The pharmaceutical industry is required...
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Roche moves closer to US filing for alectinib – Courtesy(PMLiVe)
Pharma Live, , Regulatory Affairs, 0
Positive data from two trials of Roche’s ALK inhibitor alectinib in lung cancer will be used to support a...
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Medical Dictionary for Regulatory Activities (MeDRA) by ICH
Pharma Live, , Regulatory Affairs, 0
The factsheet provides information on how organisations can access the Medical Dictionary for Regulatory Activities (MedDRA), as well as...
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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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What Is the Industry Underestimating About An ADC Supply Chain? – Part 2 – Courtesy (pharmaceutical Online)
Pharma Live, , Regulatory Affairs, 0
In What Is the Industry Underestimating About An ADC Supply Chain? – Part 1, I spoke with industry experts from...