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
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
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 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
Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft
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 US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis