Healio9h
Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
federalnewsnetwork.com23h
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
Halted research, disciplined doctors: internal audit finds Kaiser ignored patient protections in Northern California study
Many of modern medicine’s most remarkable achievements have been accomplished through the trust of volunteers, who test new ...
How a 'secret' recording threatens Delaware's largest drug case in recent years
A recently disclosed recording has appeals attorneys asking a judge to overturn the convictions of Eric "Butter" Lloyd and his codefendants.
Pacific Daily News5d
LETTER: How did fireworks become widely available for New Year celebrations?
While fireworks have been legalized, the process for their sale and distribution ... Some officials may advocate for targeted inspections based on risk assessment rather than blanket 100% inspections.
JD Supra5d
Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...
JD Supra13d
FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how ...
Baking Business13d
Report: FDA needs to improve food inspection
WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the ...
Meat13d
GAO examines food inspections done by FDA
WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the Food Safety: FDA Should Strengthen Inspection Efforts to Protect the US Food ...
MedPage Today14d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
CBS News14d
How food brands and drugmakers are responding to FDA's ban of food dye Red 3
Seasoning and condiments giant McCormick said it had also "already begun the process of removing Red 3 prior to the FDA ruling" on the ... reporter for CBS News based in the Washington, D.C ...
Morningstar14d
FDA Rejects Atara's Request to Bring Blood Cancer Treatment to Market
The biotechnology company said the Food and Drug Administration's notice was based on observations from an inspection of a ... in the drug's manufacturing process or in the drug's efficacy or ...