In April 2017 the European Medicines Agency (EMA) has released a draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content,
Officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) took to the New England Journal of Medicine on Thursday to explain the wide
A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.The
EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials.
The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials.
A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of
The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in
The British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept can be
Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft