Bullia digitalis Bullia digitalis Bullia digitalis, the finger plough shell or plough snail, is a species of sea snail, a marine gastropod mollusk in the family Nassariidae, the Nassa mud snails or dog whelks. These dominant scavengers scent decaying animal matter from a considerable distance so that they converge from all directions to feed. Length: 60 mm Narrow, smooth shell with a long, pointed spire, usually light yellow or creamy, often tinged with violet or yellow. The large, oval foot is offwhite. The operculum has serrated margins. The ovate shell is elongated, subturreted, smooth and polished. It is of a reddish yellow
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