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FDA Zantac Impurity Info Sheet Out

[ Price : $8.95]

FDA says it does not have scientific evidence on which to base a recommendation to continue using or discontinue Zantac due to the...

Understanding FDA Patient Experience Data Use

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Sanofi researchers analyze FDA use of patient experience data in 2018 new molecular entity approvals to establish a baseline for f...

FDA extends Flexion sNDA Review for Zilretta

[ Price : $8.95]

FDA extends the review of a Flexion Therapeutics supplemental NDA for Zilretta (triamcinolone acetonide extended-release injectabl...

Study: Minimal FDA Policy Effects on ANDA Prices/Shortages

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A new JAMA study finds minimal effects from FDAs recent policies to expand approvals for generic drugs at risk for price spikes an...

UCB Petition on Anti-epileptic Switching Rejected

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FDA denies a 2006 citizen petition from UCB that sought labeling on all anti-epileptic drugs warning about drug switching patients...

FDA Dragged its Feet on Vaping for a Decade: NYT

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A New York Times article examines FDAs alleged foot-dragging over the last decade that allowed e-cigarette use to explode to the d...

NDA for Ultragenyx Fatty Acid Oxidation Drug

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FDA accepts for review an Ultragenyx Pharmaceutical NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation diso...

OssDsigns Cranial Accessories Cleared

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FDA clears an OssDsign 510(k) to market its Cranial PSI Accessories, which are a set of 3D-printed, patient-specific accessory dev...

FDA Misses Deadline on Blood Pressure Drugs, Group Says

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A public interest group says FDA has missed a self-imposed six-month deadline to assess levels of the carcinogen nitrosamine that ...

Wontech HairBoom Scalp Device Cleared

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FDA clears a Wontech 510(k) for its low level laser therapy hair loss treatment device, HairBoom Air.