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 » Lupin Eyes 15 New Drug Launches in U.S. by March 2013
Lupin Eyes 15 New Drug Launches in U.S. by March 2013
Lupin plans to launch at least 15 new generic products in the United States in the current fiscal year ending March 2013, as it looks to push up sales in the world’s biggest drug market. The Economic Times