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- Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studiesThe European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.raps · 8d ago↗ source
- Study: Most sponsors complete postmarketing trials, publish resultsPostmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the tim…raps · 8d ago↗ source
- FDA advisory committee backs two controversial peptidesAn advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound t…