The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."
The FDA has cleared the first blood-based test to aid in diagnosing Alzheimer’s disease, offering a less invasive alternative to positron emission tomography scans and cerebrospinal fluid testing for cognitively impaired patients.
The USPSTF's draft recommendations reaffirm osteoporosis screening for older women, call for more research on screening men, and address health disparities.
Indivior, a Virginia-based drug manufacturer, has reached an $86 million settlement with 16 U.S. states over its alleged role in the opioid addiction crisis, involving buprenorphine-based products. The settlement funds will be used for opioid addiction treatment, recovery, and prevention.
'The strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth.'
A U.S. medical professor facing fraud charges for submitting false data in Alzheimer's disease research, impacting a publicly-listed pharmaceutical company and raising integrity concerns about its drug development. The case highlights the potential consequences of research misconduct.