From fitness tracking to healthy eating to virtual doctor visits, mobile technology places an ever-expanding selection of health management tools and information at our fingertips. With clear benefits, it is no surprise that the Food and Drug Administration (FDA) is...
Tag: consulting 104 results
Last week, FDA published new guidance, Determining Whether to Submit an ANDA or a 505(b)(2) Application (CDER, 2019), to help Sponsors select the best abbreviated approval pathway for their product. While the guidance does not provide any monumental new initiatives, policies or...