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.
Kane Biotech, a biotechnology company engaged in the development and commercialization of products that prevent and remove microbial biofilms, is pleased to announce the issuance of patent no. 4999842 entitled “Antimicrobial compositions for inhibiting growth and proliferation of a microbial biofilm on medical devices” by Japan’s patent office. StockHouse