Digitalis canariensis cm large flowers with short petals and noticeable upper lip and lower lip. Bird pollination was documented (island populations of "Phylloscopus"-species). The fruit is a capsule. "Digitalis canariensis" contains cardenolids (cardiac glycosids), which are toxic in the case of an overdose. Medical use is documented (primarily historic). For reasons of species conservation it is to refrain to influence wild stocks. "Digitalis canariensis" is endemic to the Canary Islands. It grows in woody areas (laurel forest, "Erica arborea"-covered woods) of Tenerife, La Gomera and La Palma. Digitalis canariensis Digitalis canariensis is a member of the genus "Digitalis". It is commonly called
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