The ABPI also stated that it hopes that NHS processes, like accelerated drug approval
pathways and patient outcome assessments, will be restructured.
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." If anything, Zuniga argues, the lack of progress toward a vaccine shows a fresh approach is necessary: "This disease requires bold steps.
We see it at its best in her tale of how the agendas of AIDS activists and Republican deregulators dovetailed around the push for accelerated drug approval
. Activists frustrated to have, by the mid-eighties, only a tiny handful of AIDS treatments, knew that a three-year F.D.A.