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 » AstraZeneca Settles Toprol XL Lawsuit for $11 Million
AstraZeneca Settles Toprol XL Lawsuit for $11 Million
AstraZeneca and affiliates will pay as much as $11 million to settle claims the company violated antitrust and consumer-protection laws by keeping generic versions of the heart drug Toprol XL off the market. Businessweek