FDA actions, approvals, policy shifts, and compliance—how rules change timelines and probability.
The FDA’s first current Good Manufacturing Practice (cGMP) warning letter referencing AI-generated work highlights new scrutiny for life sciences manufacturers. Experts suggest that human oversight and robust quality controls are still paramount as industry adapts AI technologies.
The FDA’s first current Good Manufacturing Practice (cGMP) warning letter referencing AI-generated work highlights new scrutiny for life sciences manufacturers. Experts suggest that human oversight and robust quality controls are still paramount as industry adapts AI technologies.
READ MORE
A key vote in the U.S. Senate has blocked efforts to end the Trump administration’s pilot program using artificial intelligence for Medicare prior authorization. The news highlights persistent policy divides regarding technology’s role in healthcare cost control and patient care.
The recent death of a high-profile figure from aortic dissection highlights ongoing gaps in awareness, risk prediction, and prevention of this rare but deadly disorder. We analyze the current landscape and potential future measures for improving patient outcomes.
A prominent coalition is urging lawmakers to reject a proposed bill that aims to enforce the No Surprises Act, warning of potential escalation in abuse of the independent dispute resolution (IDR) process.
The Federal Trade Commission has settled a major lawsuit with CVS Caremark over allegations of insulin price manipulation and restricted access for diabetes patients. The move highlights ongoing scrutiny of pharmacy benefit managers and potential regulatory shifts ahead.
The FDA’s finalized guidelines for clinical testing of psychedelic compounds could pave the way for a new generation of mental health treatments—potentially impacting the future of companies with therapies like psilocybin for depression.
A bipartisan bill aiming to reduce barriers to clinical trials has gathered endorsements from nearly 200 healthcare and advocacy groups, highlighting growing momentum to reform research participation for underrepresented populations.
As states consider cutting caregiver wages amid broader Medicaid funding changes, many families supporting people with disabilities are facing grim financial instability—some on the brink of homelessness.
A debate is intensifying about the role of patient voices in FDA regulatory decisions, especially for rare diseases. Advocates argue for patient participation in advisory committees to ensure the agency’s decisions serve the people most affected.
A former research director at Mayo Clinic has filed a lawsuit alleging retaliation after raising concerns about AI safety and patient privacy, raising critical questions for the industry about oversight, transparency, and the ethical use of artificial intelligence in healthcare.
AI is often proposed as the solution to streamlining prior authorization, but the underlying imbalance in the system persists. This article explores why the debate won’t end with technology.
