Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
pharmaphorum9d
Should pharma companies outsource clinical trials?
Finally, many countries are suspicious of their patients being submitted to questionable, unapproved therapies, and the clinical trial approval process risks getting sidetracked by regulatory ...
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
The American Journal of Managed Care2d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
pharmaphorum3d
Regulatory timelines in the Asia-Pacific
Therefore, for public sites, HREC and an SSA is required for a clinical trial to commence. The most common approval process for clinical trials using unapproved medicines in Australia is via the ...
Medscape20d
Dermatology Clinical Trials and Drug Development
Prior to initiating any clinical trial, approval from an institutional review ... Efforts to expedite the drug review process at the FDA have allowed patients more timely access to new ...
Yahoo Finance21d
FluoGuide A/S Receives Approval for Phase II Trial in Head and Neck Cancer
The Phase II Clinical Trial Application (CTA) for FG001 in head and neck cancer, announced on October 7, 2024, has been granted approval under the new European process by the Dutch Central ...