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 » Three Years of Stagnant Health App Adoption
As has been tradition for some time now, every year around this time the digital health community gets a wakeup call. The Pew Internet & American Life Project published its latest report on mobile health this morning and while it is filled to the brim with helpful, encouraging statistics related to mobile health adoptions, buried deep within is an outright discouraging one. mobihealthnews