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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 ...
STAT1mon
Federal watchdog raises some concerns about the FDA’s accelerated approval program
identifying three instances where the FDA deviated from protocol during a drug approval. OIG’s report suggests Aduhelm was more of an outlier, as investigators found only three troubling ...
The American Journal of Managed Care12d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
The HHS Office of Inspector General report emphasizes the need for better documentation and oversight in the FDA's accelerated approval pathway. The accelerated approval pathway is crucial for ...
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 ...
Forbes11d
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
More broadly, the OIG report cited issues with respect to delayed or incomplete confirmatory trials for numerous drugs. A previously issued report had found that of all 278 drug applications ...
The American Journal of Managed Care8d
Evolent’s Wonsettler Sees Outcomes-Based Reimbursement as “A Healthy Tool”
The FDA's accelerated approval of aducanumab led to controversy and a congressional investigation, highlighting issues in the approval process. The HHS OIG report found deviations in 3 out of 24 ...
JD Supra24d
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.
Medscape13d
DHHS Tailors Compliance Program Guideline for Pharmaceutical Manufacturers
The OIG identifies arrangements under which physicians and other health care professionals act as "consultants," "advisors," or "researchers" in connection with the drug manufacturer's marketing ...
STAT1mon
Pharmalittle: We’re reading about FTC criticizing PBMs, an NIH policy on access to medicines, and more
The report, released by the Office of Inspector General for the Department of Health and Human Services, intended to determine whether the FDA’s contentious approval of Biogen’s Alzheimer ...
Benzinga.com1mon
STAT+: Federal watchdog raises some concerns about the FDA's accelerated approval program
identifying three instances where the FDA deviated from protocol during a drug approval. OIG’s report suggests Aduhelm was more of an outlier, as investigators found only three troubling ...