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FDA Plans Rule to Require Full Risk Info in Drug Ads

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FDA plans to publish a proposed rule by the end of the year that would require prescription drug advertisements on television, rad...

LyfeUnit Selling Unapproved Ketamine Products: FDA

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FDA warns that the LyfeUnit Web site is selling unapproved adulterated and misbranded ketamine products.

FDA Moves to Cement Complete Response Letter Transparency Policy

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FDA looks to formalize one of its most significant transparency initiatives in decades: the public release of Complete Response Le...

Companies Can Use AI to Prepare for Inspections

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Former FDAer David Elder recommends that companies qualify AI tools to assist them in preparing for and responding to FDA inspecti...

QuVa Pharma Inspection Observations

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FDA releases the form FDA-483 with three observations from an inspection at the QuVa Pharma outsourcing facility in Sugar Land, TX...

Vera Therapeutics' Trutakna Approved for IgA Nephropathy

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FDA grants Vera Therapeutics an accelerated approval for Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary im...

FDA Cites Lundbeck Over Vyepti Promotional Claims

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FDA sends Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials for its migraine therapy Vyep...

Saol Therapeutics Resubmits Rare Disease Therapy SL1009

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Saol Therapeutics refiles its NDA for SL1009 (sodium dichloroacetate), an investigational treatment for pyruvate dehydrogenase com...

MDUFA Performance Goals, Procedures for 2028-2032

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FDA releases the draft MDUFA performance goals and procedures approved by CDRH and CBER for the 2027 renewal of MDUFA that will co...

OIG Backs Manufacturer-Sponsored Patient Tests

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Two Sheppard attorneys discuss an HHS Inspector General advisory opinion backing a drug companys arrangement with a third-party la...