FDAs
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Weighing the Evidence: Response to the FDA’s Recent Panel on Antidepressant Use in Pregnancy.
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On Monday, the US Food and Drug Administration convened an expert panel to discuss the use and safety of selective serotonergic reuptake inhibitors ...

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Are Hundreds of Companies Ignoring FDA’s User Fee Requirements?
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Since the U.S. Food and Drug Administration (FDA) launched the Over-the-Counter Monograph User Fee Program (OMUFA) in 2020, the Agency has been pushing for ...

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Unpacking the FDA’s Vaccine Approval Timeline
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In 2012, a deadly outbreak of meningitis swept across a college campus in the Northeast, leaving students terrified and public health officials ...

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Humane World for Animals and Humane World Action Fund applaud FDA’s historic move to phase out animal testing for biologics and drugs
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Announcement marks a pivotal shift in emphasis to modernize drug testing everywhere and reduce animal suffering  WASHINGTON (April 11, 2025)—Humane World ...

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FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft
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FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions ...

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Gone in a Puff of Smoke? FDA’s Proposed Rule on Maximum Nicotine Levels
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During the final week of the Biden administration, on January 15, 2025, FDA issued a proposed rule that, if finalized, would establish a maximum nicotine ...

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