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.
Israeli biotechnology firm Atox Bio said the FDA has granted fast track designation to AB103, its product in development for the treatment of necrotizing soft tissue infections, also known as flesh-eating bacteria. Reuters