Penstemon digitalis Penstemon digitalis Penstemon digitalis (foxglove beard-tongue, foxglove beardtongue, or talus slope penstemon) is a plant in the plantain family, Plantaginaceae. The flowers are white and are borne in summer. It is native to eastern Canada and eastern and southeastern United States. "Penstemon digitalis" is a glabrous 3 to 5 foot tall herbaceous plant with opposite, shiny green, simple leaves, on slender, purple stems. The leaves are up to 5 inches long. While upright, the stems average anywhere from 2 to 3 feet tall. The flowering panicle extends to almost one third of the plant's height and has pairs of branches
New Drug Application Review should complete within 6 months. The decision comes in a "Complete Response Letter". Biologics, such as vaccines and many recombinant proteins used in medical treatments are generally approved by FDA via a Biologic License Application (BLA), rather than an NDA. The manufacture of biologics is considered to differ fundamentally from that of less complex chemicals, requiring a somewhat different approval process. Generic drugs that have already been approved via an NDA submitted by another maker are approved via an Abbreviated New Drug Application (ANDA), which does not require all of the clinical trials normally required for a new drug