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 » JHP Pharmaceuticals to Produce Lyophilized Biologic for International Late-Phase Clinical Trials
JHP Pharmaceuticals to Produce Lyophilized Biologic for International Late-Phase Clinical Trials
JHP Pharmaceuticals, a provider of global contract manufacturing services for sterile products, has entered into an agreement with an undisclosed pharmaceutical company to produce supplies of a lyophilized biologic for international, late-phase clinical trials. MarketWatch