The American Journal of Managed Care11d
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 ...
USDA inspector general didn't order 'mass extermination' of birds to drive up cost of poultry, eggs
Although it is standard procedure to kill flocks with the outbreak of bird flu, posts on social media twisted the truth.
Hosted on MSN28d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
The FDA needs to strengthen guardrails to ensure its accelerated approval pathway is used appropriately, the HHS Office of Inspector General (OIG) said. The agency should do two things ...
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 ...
FiercePharma29d
Government watchdog recommends tweaks to FDA accelerated approval program
In reviewing 24 accelerated FDA approvals, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) uncovered issues with just two other nods: those for Sarepta ...
The American Journal of Managed Care6d
Evolent’s Wonsettler Sees Outcomes-Based Reimbursement as “A Healthy Tool”
Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...
JD Supra2d
FCA Enforcement Risk Remains for Rare Disease Stakeholders
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...
JD Supra23d
New HHS-OIG Guidance on Sponsored Genetic-Testing Programs
Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic testing for an ultra-rare genetic condition.