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 » PhRMA Asks Supreme Court to Reverse 3rd Circuit’s ‘Rogue’ Anti-Pay-for-Delay Decision
PhRMA is asking the Supreme Court to take up and overturn the 3rd Circuit Court’s decision that reverse patent settlements between generics and branded drug makers violate antitrust law. The trade organization submitted an amicus brief this week in support of Merck and Upsher-Smith’s petitions for a Supreme Court ruling after the 3rd Circuit created a split among the U.S. appeals courts on the issue. Drug Industry Daily