FDA BRIEF: Week of September 12, 2016
- doesn’t regulate drug prices – prices are set by the drug makers or distributors.
- does approve new drugs, including generic versions of a drug, to improve competition in the marketplace.
- Office of Generic Drugs prioritizes and expedites our review of applications for first generics
- roadmap developed for expedited access
FDA Facilitates Research on Earlier Stages of Alzheimer’s Disease
Alzheimer’s disease is a nightmare
- > 5 million diagnosed, 6th leading cause of death, most common cause of dementia
- limited treatment options
New Paths for New Alzheimer’s Drugs
2013 DRAFT GUIDANCE
- focus clinical trials on stages before the onset of overt dementia
- earlier and more precise identification of patients with early brain changes
- earlier interventions, before further extensive brain damage, more successful
- Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study, funded in part by the National Institute on Aging.