Fixed-dose combinations (FDCs) reduce the number of pills that must be taken, but they have also been a topic of concern, mainly because of the perceived potential for increased adverse events. PTE speaks with researchers to explore the benefits and concerns of FDCs.
The past few years have witnessed some dreary numbers in both Europe and the US when it comes to new products, but 2011 figures released by the European Medicines Agency may be early indicators for a 2012 upturn.
Multilayer tablets can be challenging, but meeting regulatory expectations is crucial. We speak with Vilayat Sayeed from the FDA, to find out more about the critical factors that need to be fully understood.