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 » New Tax Will Hurt Medical Device Innovation
The United States is the global leader in medical technology and medical device development, shipping over $136 billion in goods, paying $24.6 billion in salaries to 423,000 American workers and is responsible for more than 2 million American jobs. This American success story is one of the bright lights in an economy still on the rebound. The Hill