An official from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science (OPS) provided a presentation on the state of the proposed Generic Drug User Fee Act(GDUFA), which ...
Officials with the FDA have announced virtual public meetings to discuss the Animal Drug User Fee Act (ADUFA) and Animal ...
A new draft guidance document published by the US Food and Drug Administration (FDA) is aimed at clarifying which information should be included in an investigational device exemption (IDE) ...
“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, ...
Celltrion has obtained the Food and Drug Administration’s clearance for a new presentation of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), in a 45mg/0.5ml solution in a ...
The new prefilled syringe has the same composition but removes the need for reconstitution. The Food and Drug Administration (FDA) has accepted for review the regulatory application for a new ...
In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule)[1] to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) ...
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