Niphates digitalis Niphates digitalis Niphates digitalis, the pink vase sponge, is a species of demosponge belonging to the Niphatidae family. It is native to the Florida Keys, The Bahamas, and the Caribbean including the Netherlands Antilles. The species was first described by Jean-Baptiste Lamarck in 1814. The pink vase sponge is a demosponge that can grow up to 50 cm in height and width, but is more commonly smaller. It is re normally vase-, tube-, or cup-shaped with a narrow base and broader top, and somewhat flattened when viewed in cross section. Rarely, it can grow as a fan shape. Despite its
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