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Meeting Transcript on Cybersecurity Patient Messaging

[ Price : $8.95]

FDA makes available a transcript of a 9/10 Patient Engagement Advisory Committee that recommended the agency develop standards for...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Glenmark Pharmaceuticals, Torrent Pharmaceuticals, Coral Pharmaceut...

Akorn Betamethasone Dipropionate Lotion Approved

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FDA approves an Akorn ANDA for betamethasone dipropionate lotion USP, 0.05%, a corticosteroid indicated for relieving inflammatory...

QS Violations at Denterprise International

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FDA warns Denterprise International about Quality System and Radiological Health violations in its work as a specification develop...

FDA Zantac Impurity Info Sheet Out

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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

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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...