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 » Man With Defibrillator Wants to Know What His Heart Is Saying
Man With Defibrillator Wants to Know What His Heart Is Saying
Hugo Campos has a small computer buried in his chest to help keep him alive. But he has no idea what it says about his faulty heart. All the raw data it collects, especially any erratic rhythms it controls with shocks, goes directly to the manufacturer. And some of it later gets sent to his doctor. San Jose Mercury News