The European Medicines Agency says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides — essential documents that are not listed…
The FDA granted expedited review to Humacyte’s tissue therapy under the new Regenerative Medicine Advanced Therapy pathway — one of the first products to receive the designation established by the…
The EMA is recommending the European Commission suspend sales of more than 300 generic drug formulations approved using flawed bioequivalence studies conducted at two Micro Therapeutic Research Labs’ facilities in…
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…
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
EuroPharma has received a GMP non-compliance statement from the Danish Medicines Agency (DMA). Source: International Pharmaceutical Regulatory Monitor
The EMA said 30 drugs across four therapeutic classes have received conditional marketing authorization in the EU since the expedited approval pathway became available a decade ago. Source: International Pharmaceutical…