Digitalis and blue halos around lights), convulsions, and deadly disturbances of the heart. For a case description, see the paper by Lacassie. Vincent van Gogh's "Yellow Period" may have been influenced by digitalis therapy which, at the time, was thought to control seizures. As noted above, other oculotoxic effects of digitalis include generalized blurry vision, as well as seeing a "halo" around each point of light. In some instances, people have confused digitalis with the relatively harmless comfrey ("Symphytum") plant, which is often brewed into a tea, with fatal consequences. Other fatal accidents involve children drinking the water in a vase
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