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 ...
A new draft guidance document published by the US Food and Drug Administration (FDA) is aimed at clarifying which information should be included in an investigational device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 ...
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) ...
The Food & Drug Administration approved a multi-dose vial presentation of Audenz, a vaccine made by Summit-based Seqirus for individuals six months and older against bird flu, also known as influenza ...
Credit: Coherus BioSciences. The new autoinjector is designed with push-on-skin activation to be used in both in-office and at-home settings of care. The Food and Drug Administration (FDA) has ...
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 ...
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