A European Medicines Agency committee proposed changes to clarify ambiguities in an international draft guideline for non-clinical studies of oncology drugs. Source: International Pharmaceutical Regulatory Monitor
Sponsors would like to see clearer recommendations for non-inferiority assessments, demonstrating bioequivalence and targets for statistical analysis, before the European Medicines Agency adopts an international guideline on large clinical trials…
The UK’s antitrust regulator alleges that Actavis and Concordia entered a pay-for-delay agreement to block the market entry of generic versions of hydrocortisone tablets and fix prices. Source: International Pharmaceutical…
The EMA revised Q&A guidance on pharmacovigilance fees, clarifying which sponsors and assessments are subject to charges. Source: International Pharmaceutical Regulatory Monitor
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Life Sciences Jobs ... Source: BioSpace
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