A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel.
Home » Takeda Pharmaceutical Bolstering Presence in Russia, Brazil
Takeda Pharmaceutical Bolstering Presence in Russia, Brazil
Takeda Pharmaceutical is rapidly expanding its business in emerging countries, such as Russia, Brazil and China, as part of its global growth strategy. The drugmaker hopes to raise the proportion of sales in emerging markets in its total group sales to 20 percent in fiscal 2016 from the current 13 percent. Daily Yomiuri