Digitalis thapsi many characteristics of "D. purpurea" after four to five generations of cultivation, and that the former became indistinguishable from the latter, a report that was considered "probably" trustworthy by Charles Darwin. "D. thapsi" and "D. purpurea" hybrids are generally fertile. "Digitalis thapsi" is widespread in Spain. A biennial evergreen plant, it flowers in late spring. A study of the fruiting activity in "D. thapsi" showed that production, size and number of seeds were interrelated. Analysis has shown that seed weight is not related to the length of the cotyledon, and that the length of the fifth leaf can serve as
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