The last section addresses regulatory aspects, including US, European, and other international regulatory guidelines; generics, biosimilars, and over-the-counter drugs; accelerated drug approval
and expedited access of new therapies, post-drug approval activities; drug master files and European dossiers; commissioning and qualifications; quality systems and controls; safety, toxicology, and pharmacogenomics; and advancing public health.
Accelerated drug approval
was one of most important accomplishments of early AIDS activism.
When you look at the way activists both in the streets and behind the scenes pushed for accelerated drug approval
, there is no feeling that that was grandstanding or a publicity stunt.
Based on this Phase II clinical trial, Onyx could seek accelerated drug approval
from the FDA by the end of 2010.
The Company was advised by the FDA to develop CAI-O under the Accelerated Drug Approval
Track for treatment of solid cancers (colon, breast, lung, prostate, etc.