Digitalis purpurea M gene determines the production of a purple pigment, a type of anthocyanin. The m gene does not produce this pigment. The D gene is an enhancer of the M gene, and leads it to produce a big amount of the pigment. The d gene does not enhance the M gene, and only a small amount of pigment is produced. Lastly, the W gene makes the pigment be deposited only in some spots, while the w gene allows the pigment to be spread all over the flower. This combination leads to four phenotypes: Digitalis purpurea Digitalis purpurea (foxglove, common foxglove,
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